Job Title
Regulatory Affairs Specialist 2
Job 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.
#LI-PH1