Philips Senior Regulatory Affairs Specialist 

India, Maharashtra 

388234102

Job TitleSenior Regulatory Affairs Specialist

Job title:

• Senior Regulatory Affairs Specialist

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 10+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.

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