Regulatory Affairs Specialist

1 day ago

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

At Applied Medical, we are seeking a highly skilled Premarket Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will play a critical role in ensuring compliance with regulatory requirements during the early stages of product development.

Key Responsibilities:

  • Coordinate and manage the preparation, compilation, and submission of premarket regulatory documentation, including 510K submissions, European Union (EU) Medical Device Regulation, and other international filings.
  • Contribute to the development and implementation of regulatory strategies for new medical device products.
  • Monitor changes in regulatory landscape, including Food and Drug Administration (FDA) regulations and international standards, and assess their impact on ongoing and future projects.
  • Collaborate effectively with cross-functional teams, including Engineering, Quality and Clinical Development to gather necessary information and align regulatory activities with product development milestones.

Requirements:

  • Minimum two years of experience in Regulatory Affairs or Quality Assurance in the medical device industry.
  • Minimum one year of active experience applying design controls.
  • Experience in reviewing and approving technical documentation.
  • Technical background in engineering, biological, or physical sciences.
  • Experience effectively managing projects and developing advanced organizational skills.

Preferred:

  • Training in Quality Systems, including Quality Systems Regulations (QSRs) and Good Manufacturing Practices (GMPs) for medical devices, and International Organization for Standardization (ISO) standards.
  • Experience with mechanical and electrical medical devices.

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 and inclusion in the workplace and welcome applications from qualified candidates of all backgrounds.

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