Regulatory Affairs Specialist

Philips; Best; On-site; EUR 49,000 - 81,000; Full time

Benefits offered by this job

3% annual bonus

In-office 3 days/week

Job summary

Philips is seeking a Regulatory Affairs Specialist in Best, Netherlands, to develop global regulatory strategies for software medical devices and manage submissions across the US, Europe and Canada.

You will represent Regulatory Affairs in cross-functional teams, guide product development, audits and market releases, and support global regulatory submission planning while maintaining filings and licenses. In-office collaboration is required at least 3 days per week.

Qualifications

• Bachelor degree in biological sciences, biomedical engineering or equivalent.
• 3–5 years work experience, at least 1 year in the medical device industry.
• Ability to review and provide critical feedback on design documentation.
• Ability to communicate with regulatory agencies and consultants.
• Understanding of ISO 13485, IEC 62304, ISO 14971.
• Familiarity with EU MDR/MDD.

Responsibilities

• Develop global regulatory strategies for software medical devices throughout the product lifecycle.
• Prepare and manage regulatory submissions and approvals in US, Europe, and Canada.
• Represent Regulatory Affairs on cross-functional teams to support development, audits, and market releases.
• Support regulatory submission planning on a global scale.
• Communicate successful registrations/approvals to Business for commercial release.
• Maintain existing regulatory filings and licenses and manage updates.
• Assist with internal and external audits.
• Adhere to company policies and guidelines.

Skills

Regulatory strategy

Cross-functional work

Regulatory submissions

Communication skills

Documentation review

Education

Bachelor degree

Tools

Microsoft Office

Copilot

Job description

Job Description: Regulatory Affairs Specialist

• Location: Best, Noord-Brabant, Netherlands
• Job Type: Full time

Your role:

• Develop global regulatory strategies for software medical devices ensuring ongoing compliance throughout the product lifecycle.
• Prepare and manage regulatory submissions and approvals in the US, Europe, and Canada.
• Represent Regulatory Affairs on cross-functional teams, providing guidance to support product development, audits, and market releases.
• Support in creating regulatory submission planning globally
• Communicating successful registration/regulatory approval to Business for commercial release
• Maintaining existing regulatory filings/ licenses and managing updates
• Support internal and external audits
• Complying with company policies and guidelines

You're the right fit if you have:

• Bachelor degree in biological sciences, biomedical engineering or equivalent
• 3-5 years work experience, at least 1 year of which is in the medical device industry
• Ability to review and provide critical feedback on design documentation
• Ability to communicate and interact with regulatory agencies and consultants
• A thorough understanding ISO 13485, IEC 62304, and ISO 14971
• Familiarity with the EU Medical Device Directive MDD and Medical Device Regulation MDR
• Ability to communicate effectively with QA/RA, R&D, Clinical Science and Marketing teams
• Good communication skills, written and verbal
• Proficiency in Microsoft Office applications, including Copilot
• Regulatory Affairs Certification (preferred)

How we work together

We believe that we are better together than apart. For this role, this means working in-person at least 3 days per week.

Compensation & benefits

Doing meaningful work should come with fair, transparent rewards. The base salary range for this role is €48,611 –€81,018. We determine pay within the range using objective factors, like the skills the role requires, your relevant experience and the responsibility you'll have in this role, alongside internal equity and local market considerations.
This role is eligible for 3% annual bonus, with your rewards linked to your performance and company results.

About Philips

We are a health technology company.