PhilipsRegulatory Affairs Specialist 3
Philips is hiring a Regulatory Affairs Specialist 3. Level rates it ; you can apply on Level.
AI in this role
Drive global regulatory strategy, product compliance, and market access submissions for medical devices.
Job Title
Regulatory Affairs Specialist 3Job Description
Regulatory Affairs Specialist 3
Responsible for driving regulatory strategy, ensuring product compliance, and supporting market access for medical devices across global and high surveillance markets.
Your role:
- Drive and implement global regulatory strategies and roadmaps, ensuring alignment with product marketing strategies, New Product Introductions (NPI), and requirements in high surveillance countries.
- Lead regulatory planning and execution across the product lifecycle, including submissions, product registrations (e.g., CE Marking), labeling reviews, and compliance protocols, ensuring adherence to international standards and local regulations.
- Monitor and manage regulatory risks and product safety by conducting risk assessments, handling compliance issues in systems such as TrackWise, and driving corrective and preventive actions in collaboration with cross‑functional teams.
- Collaborate with global and regional stakeholders (Regulatory Affairs, Quality, R&D, Marketing) to support regulatory filings, certification processes, UDI/GTIN activities, and continuous improvement of regulatory processes and systems.
You're the right fit if:
- You have +2 years of experience in Regulatory Affairs, Quality Compliance, or Product Development within the medical devices industry with a Bachelor’s degree, or no prior experience required with a master's degree, preferably knowledgeable in Quality Compliance or similar fields.
- Knowledge of regulatory requirements, product registrations, risk management, regulatory submissions, labeling compliance, stakeholder management, and continuous improvement methodologies.
- Experience with high surveillance markets, familiarity with regulatory systems (e.g., TrackWise), strong analytical and problem‑solving skills, and RAPS RAC certification is a plus.
- Bachelor’s or Master’s degree in Biomedical Engineering, Health Sciences, Pharmaceutical, Business Administration, Law, or a related field.
- Ability to fluidly communicate in English is required.
How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.t.
This is an in office role with Administrative shift.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.
How we rate this
Regulatory Affairs Specialist 3 at Philips rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.
Little AI. AI is not part of the work.
- ●●●● Builds AI80 to 100
- ●●●○ Works on AI60 to 79
- ●●○○ Uses AI40 to 59
- ●○○○ Little AI0 to 39
Levels come from how often the tools, models and workflows of the role are named in the posting itself. Open the description and count.
Prepare for this job
A free preview built only from this posting: what it asks for, what you could be asked in an interview, and how to adjust your resume.
Skills and AI tools this role asks for
Questions you could be asked
- Tell me about a project where regulatory strategy was part of your work. What did you do?
- Tell me about a project where risk assessment was part of your work. What did you do?
- Tell me about a project where compliance was part of your work. What did you do?
- Tell me about a project where medical devices was part of your work. What did you do?
- Tell me about a project where stakeholder management was part of your work. What did you do?
Adapt your resume
- List these exact terms on your resume: Regulatory Strategy, Risk Assessment, Compliance, Medical Devices, and Stakeholder Management. An applicant tracking system matches the wording, not the idea.
- Attach one line of real, concrete experience to at least one of them — a tool named with nothing behind it rarely survives a human read.
Want an expert to read your CV for this job?
Free. Send your CV and the role you want next. We reply by email within 2 to 4 business days.
Get new AI jobs by email
One email a week with the new AI jobs, each rated for how much AI is in the work. No recruiter spam, unsubscribe in one click.
Free. One email a week. Unsubscribe in one click.
Similar roles
Other roles that involve little AI, at other companies.
What kind of AI work fits you?
Answer 12 practical questions in about three minutes. Get a simple profile, the work it points to, and live roles to explore next.
Find my next step