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Senior Regulatory Affairs Specialist
Philips
posted 16hr ago
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Flexible timing
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Job Description
- The Senior Regulatory Specialist will develop and execute the regulatory strategy for new product development, design changes and field safety corrections for US, EU and RoW.
- Collaborate with the cross functional team (including R&D, design quality, marketing, supply chain etc.) to create submission contents.
- Lead 510(k) submission, preparation of EU MDR Technical Documentation, Health Canada license applications and other global registrations and work with global regulators/competent authorities throughout review and approval process.
- Supports activities required to maintain regulatory compliance as new or revised versions of standards, guidance documents are published.
- Monitor global regulatory landscapes and supports implementation of regulation changes and executes quality plans to minimize business impact.
- Provides Regulatory assessment of product changes for launch and sustaining activities.
- Review labelling, marketing materials, and claims substantiation evidence to maintain compliance with global requirements.
- Identify areas for improvement for efficiency and compliance in internal processes, work instructions, and forms and apply technical expertise to process improvement efforts.
- May lead or participate in process improvement teams to affect changes at a local or cross business unit level.
Job Requirements/Qualifications:
- Minimum of 15+yrs years of experience in the medical device industry with regulatory submission experience. 510(k) submission experience preferred.
- Minimum of a bachelor s degree in engineering or a related scientific field. Degree within Regulatory Affairs and/or Regulatory Affairs Certification is preferred.
- Proficiency in understanding, interpretation, and the application of FDA 21 CFR 820 Quality System Regulations, EU MDR Regulation 2017/745, ISO 13485, and other relevant standards and regulations.
- Prior experience supporting/leading regulatory submissions such as 510k, EU MDR Technical Documentation and global registrations
- Strong written, oral, and interpersonal communication skills to be able to work in a team environment.
- Solution and detail oriented, well organized and self-motivated.
Employment Type: Full Time, Permanent
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Flexible timing
Monday to Friday
No travel
Day Shift
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Philips Pune Office Location
Pune Office
Philips Medical System, No.6, 2nd Floor, Dinkar Smruti, Shivajinagar, Bhamburda
Pune
Maharashtra 411005
Maharashtra 411005
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