Software MedDev Regulatory Affairs Specialist (Hybrid 3x/wk)

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

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.