Regulatory Affairs Specialist

4 weeks ago

Carlsbad, United States Meet Full time
Regulatory Affairs Manager

Meet is seeking a highly skilled Regulatory Affairs Manager to join their QA/RA department. As a key member of the team, you will be responsible for leading the regulatory strategy and managing submissions for new product launches.

Key Responsibilities:

  • Develop and implement regulatory strategies for new product development and commercialization.
  • Prepare, review, and submit regulatory documentation to relevant regulatory bodies (e.g., FDA, EMA) to obtain necessary approvals for new products.
  • Ensure compliance with all applicable regulatory requirements and standards throughout the product lifecycle.
  • Coordinate and manage regulatory submissions, including premarket notifications (510(k)), premarket approvals (PMA), and CE marking.
  • Liaise with regulatory authorities and respond to inquiries to facilitate the approval process.
  • Provide regulatory guidance to cross-functional teams, including R&D, Quality, Marketing, and Clinical, to ensure alignment with regulatory requirements.
  • Monitor and interpret regulatory requirements and changes, ensuring the company's products and processes comply with current regulations.
  • Develop and maintain regulatory files and documentation, ensuring accuracy and completeness.
  • Participate in risk management activities and provide regulatory input for risk assessments.

Requirements:

  • Bachelor's degree and a minimum of 5 years of regulatory affairs experience in the medical device industry, with a focus on premarket submissions.
  • Proven track record of successful regulatory submissions and product approvals.
  • Strong knowledge of regulatory requirements and guidelines, including FDA, ISO, and EU MDR.
  • Hands-on experience with regulatory submissions, including 510(k), PMA, and CE marking.
  • Excellent organizational, communication, and interpersonal skills.
  • Ability to manage multiple projects and priorities in a fast-paced environment.
  • Experience with electronic submission systems (e.g., eCTD) is preferred.

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