Regulatory Affairs Specialist - Software Medical Devices

Philips Iberica SAU; Best; Hybrid; EUR 49,000 - 81,000; Full time

Job summary

Philips Regulatory Affairs Specialist role to develop global strategies for software medical devices and manage submissions in US, Europe, and Canada. In-person collaboration with cross-functional teams supports product development, audits, and market releases.

Requirements include a biomedical sciences background with 3-5 years in medical devices, ISO 13485/IEC 62304/ISO 14971 knowledge, and strong communication with regulators and internal teams. Hybrid work pattern.

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 and interact with regulatory agencies and consultants.
• Understanding of ISO 13485, IEC 62304, ISO 14971.
• Familiarity with EU MDR/MDD.
• Strong communication with QA/RA, R&D, Clinical Science and Marketing teams.
• Proficiency in Microsoft Office applications, including Copilot.
• Regulatory Affairs Certification (preferred).

Responsibilities

• 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.
• Coordinate all activities related to regulatory submissions and approval for software medical devices.
• Prepare, coordinate, and file regulatory submission documents for the US, Europe, and Canada.
• Support in creating regulatory submission planning globally.
• Communicate successful registration/regulatory approval to Business for commercial release.
• Maintain existing regulatory filings/licenses and manage updates.
• Support internal and external audits.
• Comply with company policies and guidelines.

Skills

Design reviews

Regulatory liaison

Audits

Cross-functional teamwork

Documentation review

Education

Bachelor's degree in biological sciences or equivalent

Regulatory Affairs Certification (RAC) preferred

Tools

Microsoft Office

Copilot

Job description

Philips Regulatory Affairs Specialist role to develop global strategies for software medical devices and manage submissions in US, Europe, and Canada. In-person collaboration with cross-functional teams supports product development, audits, and market releases.

Requirements include a biomedical sciences background with 3-5 years in medical devices, ISO 13485/IEC 62304/ISO 14971 knowledge, and strong communication with regulators and internal teams. Hybrid work pattern.