Regulatory Affairs Specialist

2 days ago

Rancho Santa Margarita, California, United States Applied Medical Full time
Premarket Regulatory Affairs Specialist

Applied Medical is a leading medical device company with a strong commitment to innovation and excellence. We are seeking a highly skilled Premarket Regulatory Affairs Specialist to join our team.

The successful candidate will play a critical role in ensuring compliance with regulatory requirements during the early stages of product development. This includes coordinating and managing the preparation, compilation, and submission of premarket regulatory documentation, including 510K submissions, European Union (EU) Medical Device Regulation, and other international filings.

The ideal candidate will have a strong technical background in engineering, biological, or physical sciences, and experience in reviewing and approving technical documentation. They will also possess excellent writing, verbal, and interpersonal communication skills, as well as the ability to work independently and as part of a team.

The Premarket Regulatory Affairs Specialist will be responsible for:

  • Developing and implementing regulatory strategies for new medical device products
  • Coordinating with global team members on evolving regulatory requirements, standards, and guidelines in various markets
  • Monitoring changes in the regulatory landscape and assessing their impact on ongoing and future projects
  • Providing recommendations for mitigation strategies to ensure compliance
  • Collaborating with cross-functional teams, including Engineering, Quality, and Clinical Development to gather necessary information and align regulatory activities with product development milestones

The successful candidate will have a minimum of two years of experience in Regulatory Affairs or Quality Assurance in the medical device industry, with a strong understanding of domestic and international regulations, standards, and guidance documents.

We offer a competitive compensation range, comprehensive benefits package, training and mentorship opportunities, on-campus wellness activities, education reimbursement program, 401(k) program with discretionary employer match, and generous vacation accrual and paid holiday schedule.

Applied Medical is an Equal Opportunity Employer. We are committed to diversity, equity, and inclusion, and welcome applications from qualified candidates from diverse backgrounds.

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