Regulatory Affairs Manager

Job Title

Regulatory Affairs Manager

Job Description

Purpose:

• In this role, you have the opportunity to make life better through supporting the Personal Health innovation teams in bringing products to the market, complying with external regulations and standards and with company product safety & compliance policies. You will be guiding the business through the regulatory landscape, all within a competitive environment. Your role is end to end responsibility for class I and class II medical device product group and non-medical consumer product group of the same technology as the Medical device.

Your responsibilities:

• Participation in Product Development Teams (medical device and consumer products).
• Take ownership of regulatory submissions such as but not limited to initial registrations, changes/variations, and international renewals.
• Approbation plans, Regulatory Strategy Plans
• Work with applicable test houses, notified body and other regulatory authorities.
• Responsible for the preparation and maintenance of the European Technical File for CE marking
• Responsible for end to end 510(k) clearance in the U.S Experience with EU MDR
• International medical device submissions

You are a part of:

• Business Personal Health – Mother & Childcare / Women’s Health and work in our Research & Development Netherlands organization located in Eindhoven. We develop medical and non-medical products and are responsible for innovation, product research, development, industrialization, and post market activities.  You are part of a multidisciplinary organization with over 300 colleagues where the colleagues in Drachten and Eindhoven (Netherlands) as well as Hong Kong and Shenzhen. In this role you will drive from within early collaboration with the R&D team ensuring that our products meet the Safety, Compliance and Regulatory and set up to achieve successful market access. You report to Team lead of RA, MCC Business in Netherland.

You're the right fit if:  

• University Degree
• 5 years of experience in product development projects of electronics in medical devices (consumer products a plus)
• Experienced in Risk Management (IEC 14971)
• (Previous) experience with successful 510k clearance
• (Previous) experience with MDD and MDR Technical file for Class I and Class IIa products
• Experience with EUDAMED, UDI requirements.
• Proven analytic capabilities and product knowledge – system thinking.
• A network-oriented mind-set and ability to interact with different business functions at all levels.
• Technical writing and project management skills
• Very good English and Chines Skills required

Furthermore, you are:

• conceptual, analytical, data driven, and also hands-on, getting things done mentality.
• a subject leader and also a team player
• a good communicator skilled in managing interpersonal processes.
• quality oriented and solution seeking mind-set.