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Philips Senior Regulatory Affairs Specialist 
India, Maharashtra 
388234102

13.09.2024
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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