Rainer Voelksen, FRAPS
Rainer Voelksen has accumulated an outstanding experience in medical technology regulations since 1991 in different companies and government offices in different regions of the world. He started his career in regulatory affairs with a French veterinarian pharmaceutical company near Nice, France. Two major osteosynthesis/joint prosthesis manufacturers in Switzerland followed.
For two years Voelksen was the director of regulatory affairs Europe for US biotech company Genzyme, based in the Netherlands. He worked closely in EUCOMED and other structures to lobby for new human tissue regulations. In 1998, he joined the Swiss Government regulator for medical devices, which became Swissmedic, the competent authority for all therapeutic products in 2002. In 2005, he joined the Australian Therapeutic Goods Administration (TGA) for a one-year delegation from Swissmedic. After that year, he built up the Asia Pacific regulatory network for Synthes, a world leader in trauma products, being based in Sydney, Australia.
Back in Europe, he joined GE Healthcare in Paris as the executive for regulatory and quality affairs, later Edwards Lifesciences as vice president of international regulatory affairs. After some years at Swiss Federal Office of Public Health as project manager to implement the upcoming new European medical device and IVD regulations into Swiss law, he recently joined the Occlutech Group as vice president of regulatory and quality affairs.
Being a member of RAPS for more than 20 years, Voelksen served as chairman of RAPS board of directors. He was awarded the RAPS Fellow distinction in September of 2008, making him one of the first RAPS Fellows. He serves as the co-chair of the European advisory committee of RAPS. By training, Voelksen is a marine biologist, having studied in Oldenburg, Germany and Brest, France, added by a research project in Villefranche-sur-mer, France.
Q: Tell me about your career in regulatory. How did you get started? Do you have any specialties in the industry?
Originally, I trained to be a marine biologist. I didn’t plan to go into the regulatory career path, but I was drawn to the industry after my first biology research project. A French company was looking for a native German speaker with a science background, and offered me a position in regulatory affairs. The industry’s mixture of scientific and diplomatic skills interested me, so I took the position. Since then, my career has taken me in many different directions within the industry.
I quickly learned how necessary interpersonal collaboration is to this job. Regulatory professionals are responsible for "marketing" the scientific know-how of companies to regulators. To do this, we must combine scientific knowledge with people skills. Learning from a good manager is invaluable. I was lucky to have a wonderful manager to train me at the start of my career. We traveled together, allowing me to learn how to work across departments and think from a marketing and sales standpoint.
A switch to the medical device industry saw me become responsible for trademarks. I learned to work closely with patent officers to help protect the knowledge of my company. The regulatory industry must work very closely with legal, especially in this niche. Issues must be handled with a mind to know how a company can protect itself in an international market.
Q: You’ve been a volunteer with RAPS for a long time, even serving as the chair of the RAPS board of directors in 2015. What inspired you to start volunteering for RAPS?
I found RAPS when searching for additional career training. Contacting RAPS was an important milestone in my career. I attended meetings and workshops, as well as networked with others in the industry. The ability to discuss common industry concerns with peers who understand confidentiality was invaluable. Plus, the RAPS Code of Ethics emphasis on personal responsibility and transparency appealed to me. My friends at RAPS helped support me during the early years, helping me find my feet in a tough job full of ethical pitfalls.
Networking with RAPS is the key to developing regulatory career skills beyond what you can study in a book. My peers at RAPS have helped me develop comprehensive strategies both for my career at large and in my day to day job. As RAPS helped me find my way in the industry when I was getting started, I wanted to give time back.
Q: At the moment, you are a member of the RAPS European advisory committee. Can you tell me more about the committee and its goals?
The RAPS board of directors has always had European members, but with RAPS focusing more on the European market we felt there needed to be a larger pool of European volunteers advising the board on the latest development needs in Europe. The EAC’s purpose is to give a voice to the variety of concerns and needs of the European regulatory community.
There are a lot of changes in Europe right now, especially with the UK leaving the European Union. . For instance, this will have a major influence on the European Medicines Agency (EMA) as it has to relocate. In the medical devices area the two new regulations (Medical Devices Regulation MDR and In-vitro Diagnostics Regulation) have just been published. Our goal is to make sure that the concerns of all European members are being heard by the RAPS board of directors and RAPS staff. For many working in Europe, English is not their first or even second language. There are many concerns they have in their careers that are different from their peers in the United States. We recognize that RAPS can serve as a valuable resource for those working in Europe, so we need to help RAPS understand the unique needs of the market.
Q: How did you get involved with the committee and what has your role been?
The committee started when Sherry Keramidas, RAPS’ previous executive director, asked me to consult with the board on European concerns. When RAPS strengthened its focus on Europe, I, together with Philippe Auclair, helped to develop the committee into what it is today. Now the EAC meets with the board of directors a few times a year, including a face to face meeting at Convergence, to feed them information on the changing needs.
My co-chair Philippe is based in the headquarters of the Europe Union in Brussels. Between the two of us, we have helped source other volunteers in strategic locations and positions to help broaden the reach of the committee. We are focused on spreading the message of RAPS, and increasing the value attached to the name of the organization. Europe has a different culture when it comes to volunteering than the United States. Right now, employers tend to see employees volunteering time during work hours in a negative fashion. We are working to change the outlook of companies, to help them understand the inherent value of employee volunteer work with RAPS.
Q: What does it mean to you to be a volunteer for RAPS?
Volunteering is all about giving back. I received so much value from RAPS early in my career, I feel it is time for me to do the same for others. I am at a stage in my career that I can mentor others and help with networking. Technology makes giving back so easy; I can't imagine not making an effort.
Q: Do you have any advice for someone looking to start volunteering with RAPS?
Start by contacting your local chapter, checking the volunteer lists, or reaching out to the EAC. Everyone, even those new to the industry have something important to share. Additionally, make the effort to come to Convergence, especially if you are from a country that is typically under-represented. As a global organization, RAPS is always in need of volunteers from a wide variety of countries.
Regulatory professionals need to hear the voices of those working in other countries. Just helping others to get used to hearing other languages is important, and you can be a cultural representative at the table in any stage of your career. The regulatory industry is increasingly global, but all regulators work differently. We must all work harder to become comfortable sharing information in an international space so that the industry can successfully continue to develop.
Are you interested in being a part of the European Advisory Committee? We are currently looking for new committee member nominations. Click for details!