Job Title

Regulatory Affairs Specialist

Job Description

Job title:
Regulatory Affairs Specialist

Key Responsibilities

• Ensure product compliance with global medical device regulations, including CE Marking and FDA requirements.
• Monitor, analyze, and interpret global regulatory standards and regulatory updates relevant to IGT-S and Software as a Medical Device (SaMD).
• Maintain and update internal regulatory compliance frameworks in alignment with CE Marking requirements, FDA medical device regulations, and relevant IEC/ISO standards.
• Conduct compliance assessments, gap analysis, and risk evaluations for new and existing devices.
• Conduct regulatory impact assessments for new or updated standards and drive implementation activities across internal teams.
• Collaborate closely with global teams, SMEs, and internal stakeholders to ensure alignment with global compliance requirements.
• Participate in internal and external audits, reviews, and assessments to ensure ongoing regulatory conformity and support corrective and preventive action (CAPA) processes.
• Track regulatory trends, emerging requirements, and industry best practices applicable to hardware, software, and AI/ML‑enabled medical technologies.
• Provide training and regulatory updates to team members and relevant stakeholders as standards and requirements evolve.

​Required Skills & Experience

• Minimum 8+ years of experience in medical device regulatory compliance, standards management, or quality assurance.
• Strong knowledge of global medical device regulatory pathways, including EU MDR (CE Marking) and FDA 510(k).
• Hands-on experience with relevant IEC/ISO standards such as ISO 13485, ISO 14971, IEC 62304, IEC 60601 series, IEC/TR standards, and cybersecurity-related requirements.
• Experience in supporting regulatory compliance activities for IGTS/ X-ray medical devices and Software as a Medical Device (SaMD) is highly preferred.
• Excellent analytical and problem‑solving skills with the ability to interpret complex regulatory requirements.
• Proven ability to collaborate effectively with global teams, SMEs, and cross-functional partners.
• Track and interpret relevant regulatory changes and support their deployment across teams.
• Ensure adherence to internal policies, global standards, and quality system requirements.
• Support internal and external audits with accurate, audit‑ready documentation.
• Collaborate closely with cross‑functional teams to proactively manage compliance risks.
• Strong written and verbal communication skills, with the ability to translate technical and regulatory information into clear guidance.
• Regulatory Requirements (particularly on major markets and jurisdictions, e.g. US CFR, EU MDR),Standards (e.g. 60601 series, 14971, 62304)
• Regulatory Compliance activities,• Document Review / Auditing
• Team-oriented mindset with the flexibility to work in a goal-driven, dynamic environment.
• Highly detail-oriented, well-organized, and capable of managing multiple priorities simultaneously.
• Project management skills and experience handling parallel initiatives.
• Regulatory certifications (RAC) and proficiency in additional international languages are a plus.
• Willingness to travel up to 10% as 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.
Indicate if this role is an office/field/onsite role.
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.