Philips
Freelance Regulatory Affairs Manager
Your challenge
In this role, you have the opportunity to make life better trough 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 responsibilities
Plan, generate, and coordinate regulatory submissions for product licensing per regulatory plan.
Review development documentation and ensure that the information required for submissions. and product compliance is adequate.
Review and approve product labeling and product related marketing communications.
Your profile
You have a degree in Software, Electrical, Biomedical or Mechanical Engineering, combined with experience in Regulatory Affairs and Compliance.
You have experience with 510(k) submissions.
Experience with EU and other international medical device submissions as well as in other regulatory domains (consumer products) is a plus.
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.
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.
Additional responsibilities may include:
Participation in New Product Development Teams (medical device and consumer products).
Provide Safety, Compliance and Regulatory input in these teams including but not limited to the preparation of Regulatory Strategic Plan.
Ownership of regulatory submissions such as but not limited to initial registrations, changes/variations, and renewals by:
Approbation via coordination of timely preparation of requests for Free Sale Certificates.
Work with applicable test houses, notified body and competent authorities.
Coordination and collection of specific registration information with R&D, Manufacturing, QA, and applicable departments, as vital to support registration requirements.
Assist in the preparation of the Technical File for CE marking.
Assist in the preparation of the 510(k) submission and acquire/support clearance in the U.S.
You are a part of
The Business Personal Health Mother & Childcare / Womens 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. We meet in the office an average of 3 times per week in line with our newly-adopted hybrid work concept.
In this role you will drive from within R&D that our products meet the Safety, Compliance and Regulatory rules, by checking this with relevant regulations and standards, performance and reliability requirements and Philips policies. You work closely with our central SCR organization.
To succeed in this role, you´ll need a customer-first attitude and the following:
Academic degree in Biomedical, Material, Mechanical, or Chemical Engineering or equivalent
7 years of experience in product development projects of electronics consumer products in medical devices
Experience in Safety & Compliance domains and a quality mindset
Experienced in Risk Management (IEC 14971)
Knowledge of Safety standards (like IEC 60601 and IEC 60335)
Experience in multi-disciplinary, (consumer) product development projects
A network-oriented mindset and ability to interact with all business functions at all levels.
Proactive attitude and someone who takes initiative
Conceptual, analytically strong, data driven, with a strong desire to improve organizational effectiveness structurally.