Senior Regulatory Affairs Manager
SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
Our client is a professional Medical Devices organization, based in Switzerland.
Innovative Consumer Products manufacturer.
Bring innovative consumer products to the market as quickly as possible and make the difference in Personal Care related consumer products. In this position as Senior Regulatory Affairs Manager you are in the lead. You will be working in several medical device projects.
You will be responsible to ensure that all products to be released comply with all the medical device regulations by implementing requirements, conditions and enablers. Within this role you will be linked to the Personal Care innovation area.
Your responsibilities include but are not limited to:
- Support safety/regulatory affairs to ensure that the products/business comply with all regulatory requirements and company policies
- Lead projects with significant Safety and Regulatory content
- Represent Consumer Lifestyle in international regulatory bodies on specific subjects
- Report and discuss trends in product roadmaps that could require pro-actively lobbying or building up knowledge about requirement or establishing relationships with authorities and/or certification bodies
- Compile 510K submissions
- Interact with FDA, Health Canada, Notified Body (Europe) to create the better regulatory strategy to support the different products
- Teach and coach the R&D and QA teams on regulatory requirements for medical device and good documentation practice
- Help and support the Clinical Validation team and Usability team with the regulatory requirements for those studies
- Help and support the labeling team with the regulatory requirements for O.T.C (Over the Counter) Medical device labeling
- Constant update within new regulatory requirements
A key department in this site is the “Quality and Regulatory” Department (Q&R). The Q&R-team ensures that all products meet next to the medical and non-medical regulations and standards, the performance and reliability requirements needed for the product category and overall guidelines. Next to that the Q&R Manager ensures that the site development processes meet internal standards, ISO9001, ISO13485 and FDA regulations.
- A Master’s degree in Electrical, Biomedical or Mechanical Engineering
- A minimum of 5 years’ experience in product development and Regulatory, Safety & Compliance domains in international, multi-disciplinary, consumer product development projects (required)
- Between 5 to 10 years’ experience as Regulatory Affairs within the Medical Device Industry
- Experience in R&D of durable consumer products (good but not required)
- Experience in medical device regulation (EU, FDA) (required)
- Experience in 510K and FDA (good but not required. If you do not have experience in 510K submissions, this is something that you want to learn as the next step in your career)
- Project management experience/skills, analytically strong and quality driven (required)
- Strong communicator (who shows seniority) and motivator, also at senior management level (required)
- Leadership skills, you are the RA expert and have to drive changes (required)
- Proven analytic capabilities and product knowledge
- A network oriented mindset and ability to interact with all business functions at all levels
- 32 to 40 hours available and prepared to travel 10% of your time (USA, Asia or Eastern Europe)
You are a person who:
• Likes to teach, coach and support the team and are not likely to be frustrated when explaining the same topic over and over again.
• Pro-actively read new regulations and review /submit comments to the Regulatory Authorities
• Participate in phone calls and International Conferences of trends in the new regulations
Additional Information: Our team is a very talented and energetic team. The majority of our team members are relatively new to the medical device industry, requirements and regulations. They are passionated and curious about what they need to do, and as our Senior RA Manager, you will guide them, and coach them in each step.
In the future we expect that the QA team will be doing this work, and you as Regulatory Manager will focus more in the Regulatory process (510K’s, Interaction with FDA, Health Canada, Notify Body, ), Writing Regulatory Strategy , help and support The Clinical Validation and Usability group from the regulatory requirements for those studies, among others.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Michael Lynch.