Bassil Akra | Finding your path in unexpected places
Elemed Awards | Winners 2021 | Elemed
Elemed Awards 2021 | The Winners
The Elemed Awards were created to recognise individuals and organisations that have made a significant contribution to improving patients’ lives and the MedTech industry in general.
Thank you to everyone who submitted a nomination. The competition was fierce and the results are now in. Huge congratulations to our winners who are listed below.
🏆 Up and Coming Individual – Karandeep Singh Badwal 🏆
Biography:
Karandeep is a Quality & Regulatory consultant specialising within SaMD and AI who shares his passion for MedTech via bite sized content on Linkedin, a Podcast (The MedTech Podcast) and his YouTube Channel (QRA Medical).
Quote from Karandeep:
“I am honoured to receive this award in the recognition of my work and accomplishments, I would like to thank the MedTech community, my mentors and Elemed for their regular support and strive to continue serving the Industry!”
🏆 Contribution to the Community – Rajesh Kasbekar 🏆
Biography:
Raj Kasbekar, is currently the Global Vice President of Regulatory, Quality Systems and Clinical Affairs at Helen of Troy, Health & Home. Helen of Troy is a $2 billion dollar consumer and medical device products company with leading consumer brands such as Vicks, Braun, Honeywell, Revlon, Dr Scholls and products that are sold globally. Raj Kasbekar has spent the last 25 years in organisational management, regulatory affairs, product development, clinical affairs, auditing, quality systems, program management, and product quality and has held wide-ranging positions as well as consulting at startups and major corporations. He has also published several peer reviewed articles and has patents pending. He is intrigued by the current rate of innovations in the medical device sector and is passionate about bringing new medical device technologies especially in connected products, Artificial Intelligence and gene therapy to the market.
Quote from Raj:
“I am absolutely delighted to win an award from a top-notch organisation led by a dynamic founder that has recently won the best medical device recruiting agency in the EU and globally.”
🏆 Best Supplier to the Industry – Freyr Solutions represented by Vardhini Kirthivas 🏆
Biography:
With a distinguished career spanning over two decades, there isn’t a single facet of Regulatory affairs Vardhini hasn’t mastered. Working across national as well as international market leaders for 22 years, Vardhini has risen the ranks crediting on her expertise in dealing with industry-leading, new-edge technology, the likes of futuristic software, AI, ML in medical devices and their regulations across the globe.
Currently heading the Global Medical Device business vertical at Freyr Solutions, Vardhini presides over Pre-sales, Solutioning and Delivery and has a keen interest in complex medical devices regulatory submissions.
Infamous for taking up seemingly impossible regulatory challenges, Vardhini inspires everyone to rise above and beyond every day.
Quote from Vardhini:
“Thank you ELEMED for recognizing Freyr’s contribution to the medical device industry and bestowing us with this prestigious award. It is an absolute privilege for us. I am proud of the work that we as a team have done and will surely continue to effectively understand niche regulatory requirements of the industry. I believe that a vital component of leadership stems from identifying new areas of regulatory offerings and catering to the needs of all small, midsize, and big corporations alike. Freyr is constantly on the pursuit of offering enhanced end-to-end regulatory support to make it easier for healthcare organizations, one step at a time. This award also bears testimony to our undaunted response and uninterrupted service to the industry during the SARS-CoV-2 pandemic.
In countries like India, where I am from, a significant part of the population still suffers from the lack of advanced healthcare and accurate diagnosis of ailments. It is only through the cooperation between governments and healthcare organizations, that this significant mission in improving healthcare and subsequently the lives of millions of people worldwide will be attainable. I look forward to significant growth of the medical devices industry driven by extraordinary innovation, prototyping and manufacturing. And that Freyr would be continuing to support and champion medical device as a heterogeneous, innovative, and dynamic sector.
Thank you, team. Thank you Freyr.”
🏆 Outstanding Support During Covid – GAMA Healthcare represented by Rob Cook 🏆
Biography:
“I have been privileged to have worked for some great businesses before moving from the world of ‘big corporate’ into smaller, medium-sized enterprises like GAMA Healthcare. So, why did I join GAMA? GAMA loves to innovate, create quality products that make a positive difference in healthcare systems and conduct business with integrity, which healthcare systems around the world have recognised.”
Quote from Rob:
“We’re delighted to win this award! The transition to remote working was quite new for us, but the team – and I mean everyone in the business – pulled together to stay connected and look after each other. That kind of behaviour sets up nicely for the future, whatever challenges we need to be ready for.”
🏆 Up and Coming Startup – GAAT Technologies represented by Geert van Gansewinkel 🏆
Biography:
Geert started his career as a consultant, working for Accenture and The Boston Consulting Group. In 2013, he joined Polaris, a life sciences technology company, where he was a partner and responsible for the European and Asian businesses. In 2017, Polaris was sold to IQVIA. In IQVIA, Geert held a number of global commercial roles, after which he became general manager for IQVIA in the Netherlands. In March 2020, Geert joined GATT Technologies as CEO.
Quote from Geert:
“I am excited about receiving this award. To me, this confirms that we are doing the right things, bringing our innovation to the market with the potential to impact patients’ lives globally.”
🏆 Most Collaborative MDR Implementation – Owens & Minor Halyard 🏆
Biography:
Owens & Minor, Inc. (NYSE: OMI) is a leading global healthcare services company dedicated to Connecting the World of Medical Products to the Point of Care by providing vital supply chain services to healthcare providers and manufacturers of healthcare products. We are a global healthcare services company delivering exceptional value to our customers.
Our market leading sterilization wrap, facial protection, gloves, protective apparel, surgical drapes and gowns, are sold in more than 100 countries.
We are also a market leader in the supply of Custom Procedure Trays (CPTs), in our manufacturing site in Kells, Ireland.
Healthcare professionals choose O&M Halyard because of the quality, clinical superiority and exceptional support that comes with every O&M Halyard product.
Our solutions keep pace with a complex and changing healthcare industry; protecting staff, surgical teams and ultimately supporting better patient outcomes.
Quote from Owens & Minor Halyard:
“We are honoured to have been selected as a winner for our MDR implementation. This has truly been a fantastic team effort! A big thank you to all involved teammates from Ireland and Belgium and across the EMEA region, for all the efforts that went into ensuring a seamless implementation and ultimately an excellent customer experience!”
🏆 Most Collaborative IVDR Implementation – TÜV SÜD represented by Dr. Andreas Stange 🏆
Biography:
Dr. Andreas F. Stange is a vice president for the Medical and Health Services group at TÜV SÜD Product Service. He serves as the global responsible for the In-vitro Diagnostic Devices business line.
Based in Japan, he is also overseeing TÜV SÜD`s Medical Health Services in North-East Asia and West Europe. Dr. Stange joined TÜV SÜD in 2001 as medical device expert and had various positions since then in
the group. Before taking the current position in March 2017, he was President & CEO of TÜV SÜD in Japan.
Quote from Andreas:
“Thank you for the acknowledgement and recognition of TUV SUD efforts in the IVDR implementation. Our global IVD team will feel encouraged to strive for further growth, widening our technical expertise and improve our service level. Let me also thank Elemed for helping us building up this great team.”
🏆 Most Collaborative IVDR Implementation – Tecan represented by Carsten Krafcsik 🏆
Biography:
Carsten Krafcsik held several position in the medical device and IVD industry in Regulatory Affairs and Quality over more than 15 years. He has a background as a medical device engineer and an MBA and worked on an international level in the US, Germany, Austria and Switzerland.
Starting out in the Ultrasound Industry in Colorado, USA, he held several positions in Europe for various medical devices such as dental implants, sleep apnea, ophthalmic surgery and since 2016 in Lab Automation for Tecan. He represented companies in various standardization groups, industry groups and MedTec Europe. His experiences cover Research and Development, Manufacturing, international registrations as well as strategic business development topics.
Quote from Carsten:
“We are very honored to be awarded for Best Leadership and Collaboration. It is an outstanding recognition for the whole Team being involved in the IVDR Project that worked hard to not only be ready for the Tecan own Products, but also for all our customers. It is Tecan’s mission to delight our customers by exceeding their expectations, aiming for the highest customer satisfaction.
🏆 Top Leader in MedTech – Seamus Moore 🏆
Biography:
“I started in the MedTech industry as a part time receptionist for a Medical Device manufacturer and accepted a temporary role in the Regulatory team as RA assistant and really enjoyed the challenging and complex environment of the regulatory sector, so I decided to expand my RA knowledge and started and completed a Master’s degree study through Krems Medical University in Vienna while working full time and graduated with honours.
I gained invaluable knowledge over the years working in three medical device companies, dealing with all classifications of Medical Devices and I have been very involved in making the companies compliant to the new Medical Device Regulation.
I find the world of regulatory, dynamic and rewarding , due to the ever-changing regulations and legislations worldwide and I get a kick out of achieving results with my team. I find there are always new challenges and opportunities to learn and soak up knowledge like a sponge, I thrive on it 🙂”
Quote from Seamus:
It was a complete surprise to be nominated for this award and an even bigger one to win the award. I would like to thank the person/people who nominated me. I am very moved by your confidence and belief in me. If you knew my journey in RA since the beginning, you would appreciate the effort and hard work it has taken to get me to this point in my career.
My motto in life was given to me many years ago by my mother when I first started working in the hospitality industry, she said to me “you catch more flies with honey than you do with vinegar” and this has always stuck with me and it has paid off big time when it comes to building relationships with my network of people who have supported and guided me in my journey to this stage. For me I see this as a team award for me and my team and network of supporters and its proof, that with empathy, hard work and determination you are never too old to reach for your dreams, thank you everybody 🙂”
COVID-19 and remote regulatory affairs jobs | Elemed
The impact of COVID-19 on remote regulatory affairs jobs
If you are considering hiring a new regulatory affairs team member for your medical device or IVD company, it’s important that you consider how COVID-19 has affected how regulatory affairs professionals (and professionals from other disciplines across MedTech) now approach work. After two years of working remotely, it appears the work from home approach is here to stay. As a medical device and IVD recruitment business, we’re also seeing a real trend in our candidates’ priorities. ‘Live to work’ has been replaced across the board with ‘work to live, and this shift means that candidates are now looking for more flexibility, support and empathy from their employers.
Regulatory affairs is a profession that lends itself well to remote working. Regulatory professionals often work with teams and partners across multiple countries/regions, across different time zones. The use of technology means that remote regulatory affairs workers can work virtually alongside their international colleagues at the click of a button. Remote working technology also means that teams that do face the challenge of different time zones can better accommodate working together, as it is easier to work from a home office an unusual hours that it is from a managed office space.
Offering regulatory affairs remote jobs isn’t just beneficial for employees though, it is also highly beneficial for employers. Companies that embrace remote working can now access talent pools in locations that were never possible before. They are able to take advantage of hidden gem talent pools, where there are a high concentration of qualified candidates and low supply of jobs. They are able to hire at more competitive rates, and get out of the ‘fishing in the same pool’ approach which inflates salaries and decreases retention. Employers can access a whole blue ocean of untapped regulatory affairs talent. Supporting remote working as a business can also help to decrease office and operational costs, freeing up budget to invest elsewhere in the business. Employers who champion flexible working, mental health support and a healthy work-life balance will ultimately secure the best candidates on the market.
The rise of remote working in regulatory affairs
Since the start of the pandemic, we as recruiters have witnessed first hand the shift in what regulatory affairs professionals are looking for from their next job. The pandemic has shown employers and employees alike that productivity and progress can be achieved working from home, and regulatory affairs professionals are now keen to maintain this work-life balance. We are also seeing more and more jobs coming in from medical device and IVD employers that are fully remote or hybrid working, highlighting that employers are hearing what their candidates are saying and are responding positively!
Seeking employers who are supportive and kind
Empathy at work is another big trend that we’ve seen emerge from the pandemic. COVID-19 has threatened our freedom, our health and even our lives – and the lives of the people we love. It has reminded us how precious life is, and that a more equal blend between work and life is needed to stay happy and engaged with our jobs. The impact of lockdowns, self-isolation and protecting our loved ones has taken its toll on everyone’s mental health, and employers who are stepping up to support their teams with kindness and empathy are winning employee loyalty and increased motivation as a result.
Prioritising companies who live by their values
The values you stand for as a business, and how you translate them into actions for your customers and employees, has risen to the top of candidates’ agendas. Joining an employer with a strong sense of purpose and a clear ‘why’ helps employees to feel connected to something meaningful and something that is bigger than themselves. Employers should use employer branding to communicate these values in order to attract and retain the best regulatory affairs talent.
As the regulatory affairs landscape in medical device and IVD companies shifts, and as candidate expectations change to better fit the stresses of the pandemic and the priorities it has revealed, companies need to work hard to win over the best professionals in the market. We are here to help businesses understand these changes and how to meet candidates in the middle, to offer them competitive packages that mean something more than salary and standard benefits. Get in touch with our team today to discuss your regulatory affairs opportunities, the best way to attract the talent you’re looking for, and who in our network could be a perfect fit for your team!
You can also learn more about regulatory affairs professionals around the world and their perspectives towards current issues such as the impact of COVID-19 and the level of diversity, equity and inclusion in regulatory affairs in our first-of-its-kind report (created in partnership with RAPS!). Download the report here.
Donielle Johnson | Finding purpose to life, work and everything in between
Why a person responsible for regulatory compliance is crucial in 2021
The rise of the person responsible for regulatory compliance
2021 has been an interesting year for many of us, especially regulatory compliance and regulatory affairs teams around the world. Since the start of the pandemic, regulatory compliance and affairs has had a re-brand, moving from ‘just another department’ to a key strategic partner for many businesses. This raised profile has highlighted the fact that regulatory compliance is not just about knowing the rules and regulations inside out – it’s also about exceptional negotiation skills, proactive and reactive creativity, multidisciplinary communication skills and being able to navigate the grey where other teams can’t. It’s regulatory affairs professionals who sit at the forefront of bringing products to market quickly – a responsibility which has been more important than ever in the face of Coronavirus and the need for vaccines and virus detection medical devices.
It’s not just the pandemic that has raised the global profile of regulatory affairs compliance professionals. The European Commission’s guidance in response to the new MDR 2017/745 and IVDR 2017/746, says that manufacturers and authorised representatives must have at least one member of staff who is a designated person responsible for regulatory compliance (PRRC) to the MDR and/or IVDR. So, if you’re a medical device manufacturer or authorised representative then it’s imperative that you have a PRRC on your team.
What will a person responsible for regulatory compliance do?
Under MDR 2017/745
According to Article 15(3) of the EU MDR 2017/745, the PRRC of a medical manufacturer is responsible for ensuring that:
(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
(c) the post-market surveillance obligations are complied with in accordance with Article 10(10);
(d) the reporting obligations referred to in Articles 87 to 91 are fulfilled.
(e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
Under IVDR 2017/746
For PRRCs working according to Article 15(3) of the EU IVDR 2017/746, their responsibilities are:
(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
(c) the post-market surveillance obligations are complied with in accordance with Article 10(9);
(d) the reporting obligations referred to in Articles 82 to 86 are fulfilled.
(e) in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Annex XIV is issued.
What makes a great PRRC?
Your person responsible for regulatory compliance needs to be a fantastic communicator, as they’ll need to communicate across different layers of your business, with customers and with external certifying bodies. They’ll need to have a demonstrable background of technical, protocol and report driven work, with fantastic attention to spoken and written detail. A great PRRC will also be able to show their experience in working with a flexible, proactive and hands-on approach to their work.
According to MDR 2017/745, the person responsible for regulatory compliance should have:
a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices
or
(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices
For IVDR 2017/746, the PRRC’s experience must pertain to in vitro medical devices.
When it comes to adding a person responsible for regulatory compliance to your team, you have a few options to consider. The first is to look internally for someone who has the required skills and experience. If there is no one suitable, you can either:
– Hire a new employee that will fulfil this role
– Hire a consultant for a certain period of time until one of your internal employees gets trained
PRRCs are in high demand right now and competition for the best ones is high! We’re on hand with our highly coveted network of over 20,000 MedTech professionals to not only help you find the best person for the job, but to also make sure they join your company and not a very attractive competitor.
Liam Turley | A Comeback Journey Founder, CEO and Quality Expert at Trinzo
