PhilipsRegulatory Affairs Specialist 2
Philips is hiring a Regulatory Affairs Specialist 2. Level rates it ; you can apply on Level.
AI in this role
Support regulatory strategies, product submissions, and compliance documentation for medical device projects under supervision.
Job Title
Regulatory Affairs Specialist 2Job Description
Regulatory Affairs Operations Specialist 2
This role supports the implementation of regulatory strategies and submissions for smaller-scale projects, coordinating cross-functional efforts to ensure compliance, streamline approvals, and maintain audit-ready documentation throughout the product lifecycle.
Your role:
- Supports implementation of regulatory strategies for smaller, less complex projects by collaborating with regulatory and cross-functional SMEs; assists in preparing and coordinating product submissions, conformity assessments, and change control processes to expedite approvals and maintain compliance.
- Reviews labeling, marketing communications, and development quality reports to ensure regulatory compliance; maintains documentation to support regulatory filings, audits, and UDI/GTIN-related activities.
- Works closely with internal teams and regional regulatory partners to align on regulatory standards, support establishment registrations, and advise cross-functional stakeholders on evolving regulations and requirements.
- Operates under general supervision within standardized procedures, using independent judgment and basic analytical skills to resolve less complex issues, shadowing senior specialists on sustaining and NPI projects.
- Stays updated on changes in regulatory procedures and participates in process improvement initiatives to optimize internal regulatory operations and support streamlined business outcomes.
You're the right fit if:
- Bachelor's Degree / Vocational Education in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent.
- No prior experience required with bachelor's degree OR minimum 4 years of experience with Vocational Education in Regulatory Affairs, Quality Compliance, Product Development in Medical Devices Industry or equivalent.
- RAPS RAC certification is a plus.
- 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.
This role is an 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.
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How we rate this
Regulatory Affairs Specialist 2 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 compliance was part of your work. What did you do?
- Tell me about a project where document management was part of your work. What did you do?
- Tell me about a project where quality assurance was part of your work. What did you do?
- Tell me about a project where cross functional coordination was part of your work. What did you do?
Adapt your resume
- List these exact terms on your resume: Regulatory Compliance, Document Management, Quality Assurance, and Cross Functional Coordination. 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.
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