Regulatory Affairs Manager

1 month ago

San Diego, California, United States Surf Search Full time

Join Our Team as a Regulatory Affairs Manager

We are seeking a skilled Regulatory Affairs Manager to become part of our client's team and have a significant role in introducing new products to the market. As the Regulatory Affairs Manager, you will be responsible for leading the regulatory strategy and overseeing submissions for new product releases within the cardiovascular medical device portfolio.

Qualifications Required for the Role:

  • Must hold a Bachelor's degree in a scientific, engineering, or related field. Additional certification in Regulatory Affairs (e.g., RAC) would be advantageous.
  • Minimum of 5 years' experience in regulatory affairs within the medical device sector, with a focus on premarket submissions.
  • Demonstrated success in handling regulatory submissions and obtaining product approvals.
  • Thorough understanding of regulatory requirements and standards such as FDA, ISO, and EU MDR.
  • Hands-on experience with various regulatory submissions like 510(k), PMA, and CE marking.
  • Strong organizational, communication, and interpersonal skills.
  • Capable of managing multiple projects in a dynamic environment.
  • Detail-oriented with excellent analytical and problem-solving abilities.
  • Preference for familiarity with electronic submission systems like eCTD.
  • Previous experience in a management role, guiding and supporting junior staff.
  • Passionate about contributing to the advancement of life-saving technologies within the medical device industry.

Key Responsibilities of the Role:

  • Devise and execute regulatory strategies for new product development and market entry.
  • Prepare, review, and submit regulatory documents to relevant bodies for necessary approvals.
  • Ensure adherence to all regulatory requirements and standards across product lifecycles.
  • Manage regulatory submissions, including 510(k), PMA, and CE marking processes.
  • Engage with regulatory authorities and address inquiries during approval procedures.
  • Offer regulatory advice to various teams to ensure compliance with standards.
  • Stay updated on regulatory changes and requirements to maintain compliance.
  • Establish and maintain regulatory files with accuracy and completeness.
  • Contribute to risk management activities and provide regulatory insights for assessments.
  • Guide and train junior regulatory personnel to promote a culture of compliance.
  • Oversee regulatory projects to guarantee timely product launches.
  • Collaborate with external partners and consultants for regulatory support as needed.

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