Philips Hiring Regulatory Affairs Specialist | medical device

Philips Hiring Regulatory Affairs Specialist for Global Medical Device Compliance

Healthcare technology leader Philips has announced a new hiring opportunity for the role of Regulatory Affairs Specialist in Pune. The position is designed for experienced regulatory professionals who want to work on global medical device compliance, regulatory strategy, and safety standards within advanced healthcare technologies.

As the medical device and digital health sectors expand rapidly, regulatory affairs experts play a crucial role in ensuring that innovative healthcare technologies meet strict global compliance requirements. This role offers professionals the opportunity to contribute to regulatory approval and compliance management for sophisticated medical devices and software‑driven healthcare solutions.

For professionals with experience in regulatory affairs, medical device standards, and global regulatory pathways, this role provides exposure to international regulatory frameworks such as EU MDR and FDA regulations.

Company Overview

Philips is a global health technology company focused on improving people’s health and enabling better care outcomes through meaningful innovation. The organization develops advanced medical technologies used across hospitals, diagnostic centers, and healthcare systems worldwide.

The company’s product portfolio includes imaging systems, patient monitoring technologies, healthcare informatics platforms, and software‑enabled medical devices. Philips works closely with healthcare providers, regulators, and technology partners to develop solutions that improve patient care and healthcare efficiency.

Through continuous investment in innovation and regulatory excellence, Philips ensures that its healthcare technologies comply with global safety and regulatory standards while maintaining high product quality and patient safety.

Career Outlook for Regulatory Affairs & Safety Science Professionals in 2026

Regulatory affairs continues to be one of the most important functions within healthcare technology and pharmaceutical organizations. By 2026, the demand for professionals who understand global regulatory pathways, medical device standards, and digital health compliance is expected to grow significantly.

Medical device companies must comply with complex international regulatory frameworks including EU Medical Device Regulation (MDR), FDA 510(k) pathways, and multiple ISO and IEC standards. Regulatory professionals help ensure that these requirements are met before healthcare technologies reach the market.

Professionals working in regulatory affairs often progress into roles such as Global Regulatory Affairs Manager, Regulatory Strategy Lead, Quality and Compliance Director, or Medical Device Regulatory Consultant. With increasing innovation in AI‑enabled medical devices and digital healthcare platforms, regulatory expertise will remain highly valuable across the healthcare industry.

Job Role & Responsibilities

The Regulatory Affairs Specialist will support regulatory compliance and standards management activities for Philips medical device technologies.

Key responsibilities include:

• Ensure product compliance with global medical device regulations including CE Marking and FDA requirements
• Monitor global regulatory standards and interpret regulatory updates affecting medical devices and software technologies
• Maintain internal regulatory compliance frameworks aligned with international regulatory standards
• Conduct compliance assessments, gap analysis, and risk evaluations for medical device products
• Evaluate regulatory impact of updated standards and implement required changes across teams
• Collaborate with global subject matter experts and cross‑functional teams to ensure regulatory alignment
• Participate in internal and external audits to maintain regulatory conformity
• Support corrective and preventive action processes following audit observations
• Track emerging regulatory requirements for hardware, software, and AI‑enabled medical technologies
• Provide regulatory training and updates to internal teams when standards evolve

These responsibilities ensure that Philips healthcare technologies remain compliant with global regulatory requirements while maintaining high safety standards.

Eligibility / Qualifications

Candidates applying for this regulatory affairs role should meet the following criteria:

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Pharmacy, or related healthcare discipline
• Strong knowledge of global medical device regulatory frameworks
• Ability to interpret complex regulatory requirements and implement compliance strategies
• Strong analytical and problem‑solving skills
• Excellent communication skills for collaboration with global teams

Relevant education backgrounds may include: B.Pharm, M.Pharm, B.Tech Biomedical Engineering, M.Tech Biomedical Engineering, B.Sc Life Sciences, M.Sc Biotechnology.

Experience Requirements

Philips is seeking experienced professionals with strong expertise in medical device regulatory compliance.

• Minimum 8+ years of experience in regulatory affairs, quality assurance, or regulatory compliance
• Experience with EU MDR (CE Marking) and FDA 510(k) regulatory pathways
• Knowledge of international standards such as ISO 13485, ISO 14971, IEC 62304, and IEC 60601 series
• Experience working with Software as a Medical Device (SaMD) or imaging technologies is preferred

Regulatory certifications such as RAC and experience working with global compliance frameworks may provide additional advantage.

Skills & Competencies

Professionals applying for this role should demonstrate:

• Strong knowledge of regulatory compliance frameworks
• Experience in regulatory documentation review and audit readiness
• Ability to manage multiple regulatory projects simultaneously
• Strong collaboration skills with cross‑functional global teams
• Excellent written and verbal communication abilities

Project management experience and ability to interpret evolving regulatory standards are valuable skills for this position.

Location & Work Model

Location: Pune, Maharashtra, India

Work Model: Hybrid office model requiring in‑person collaboration at least three days per week.

Travel: Up to 10% travel may be required depending on regulatory project needs.

Salary & Benefits

Salary: Competitive healthcare technology industry compensation based on experience and regulatory expertise. Global organizations like Philips typically provide comprehensive benefits packages including healthcare coverage, retirement benefits, and professional development opportunities.

Application Process

Interested candidates can apply through the official Philips careers portal using the link below.

Apply here: https://philips.wd3.myworkdayjobs.com/jobs-and-careers/job/Pune/Regulatory-Affairs-Specialist_572987

Applicants should prepare an updated resume highlighting regulatory affairs experience, compliance expertise, and familiarity with global medical device regulatory standards.

Early application is recommended as regulatory leadership roles in global healthcare companies often receive strong interest from experienced professionals.

Frequently Asked Questions

Who can apply for the Philips Regulatory Affairs Specialist role? Candidates with experience in medical device regulatory compliance, quality assurance, or regulatory strategy can apply.

Which regulatory standards are important for this role? Important standards include EU MDR, FDA 510(k), ISO 13485, ISO 14971, IEC 62304, and IEC 60601.

Is experience in Software as a Medical Device required? Experience with SaMD or medical imaging technologies is preferred but may not be mandatory for all candidates.

What career growth opportunities exist in regulatory affairs? Professionals may progress into roles such as Global Regulatory Manager, Regulatory Strategy Lead, Quality Compliance Director, or Medical Device Regulatory Consultant.

Summary

Category	Details
Company	Philips
Vacancies	Regulatory Affairs Specialist
Required Education	B.Pharm, M.Pharm, Biomedical Engineering, Life Sciences
Experience	Minimum 8+ years in regulatory affairs or medical device compliance
Location	Pune, Maharashtra
Department	Regulatory Affairs / Compliance