Regulatory Affairs Specialist

1 week ago

Bengaluru, Karnataka, India Philips Full time

Job Title: Principal Regulatory Affairs Specialist

Job Description:

Key Responsibilities:

  • Develop and execute regulatory strategies for new product development, design changes, and field safety corrections for US, EU, and RoW.
  • Author 510k submissions, lead pre-sub meetings, create EU MDR Technical Documentation, Health Canada license applications, and lead interactions with regulators/competent authorities throughout the review and approval process.
  • Participate in strategic product development, design solutions starting from concept phase to product delivery phase, and provide regulatory guidance throughout design and development.
  • Act as a Regulatory Subject Matter Expert on various aspects and provide strategic guidance to other RA Staff and project teams.
  • Monitor global regulatory landscapes and guide cross-functional teams on the implementation of regulation changes.
  • Communicate new and coming changes, facilitate/assist with interpretation to guide product and business compliance with regulatory requirements.
  • Support product defect assessments, issue impact assessments, health hazard evaluations, corrections, and removals, and CAPAs as a regulatory subject matter expert.
  • Review labeling, 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.
  • Lead or participate on process improvement teams to affect changes at a local or cross-business unit level.

Requirements:

  • Minimum of 7-10 years of experience in the Regulatory Affairs medical device industry with regulatory submission experience; 510(k) experience is preferred.
  • Preferred candidate will have a master's degree in engineering or regulatory affairs or a related field with a minimum of 7 years of experience; will consider applicants with a Bachelor's Degree and demonstrated experience working within the Medical Device industry.
  • Mastery in understanding, interpretation, and application of FDA 21 CFR 820 Quality System Regulations, EU MDR Regulation 2017/745, ISO 13485, and other relevant standards and regulations.
  • Strong written, oral, and interpersonal skills required to work in a team environment as well as individual contributor with minimal supervision.
  • Solution and detail-oriented, well-organized, and self-motivated with the ability to negotiate with regulators.
  • May require up to 20% travel.

About Philips:

We are a health technology company built 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.

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