Regulatory Affairs Manager in USA

  • Location: San Diego
  • Job type: Permanent
  • Salary: US$140000 – US$140001 per year
  • Discipline: Regulatory
  • Reference: PR/260644_1586307131

Title: Regulatory Affairs Manager

Overview

We are looking for a seasoned Medical Device Regulatory Affairs Manager to join the San Diego, CA facility at one of the largest biotech’s in the world. The Regulatory Affairs Manager role will develop Regulatory global strategy, domestic and international guidance, approval, and review. This role may include people and product management.

Responsibilities

  • Ensure regulatory compliance to FDA and international regulations
  • Providing global regulatory strategy to contribute to labeling requirements, 510(k) submissions, and product marketing
  • Work closely to provide knowledge of sterile disposable products, product biocompatibility, sterilization, and packaging requirements.
  • May manage both people and products
  • Amend current documentation and review product design
  • Verify compliance to existing regulatory submissions
  • Review content and format 510(k) and regulatory registration impact
  • Provide knowledge of FDA/ISO/EU MDD/EU MDR/ and Canadian regulatory requirements
  • Participate as a core member of the Regulatory Affairs team to develop projects and submissions
  • Work hands-on in a dynamic fast-paced environment

Experience and Qualifications

  • Minimum of 6+ years direct related professional experience in Regulatory Affairs/Quality required, preferably in the medical device/biomedical area
  • Significant knowledge and experience working with software, instrument, and disposable design practices/products
  • Ability to represent Regulatory Affairs in multiple environments (R&D, Marketing, Labeling)
  • Interpret Regulatory Affairs documents, submissions, and reports
  • Knowledge of current FDA regulatory requirements and trends for medical device premarket notifications
  • Ability to present complex regulatory information to cross-functional teams
  • Experience working and contributing to 510(k) and other regulatory submissions/documents

Education

  • Minimum of bachelor’s degree or above in a life sciences field from an accredited college or university required

If you are interested in the Regulatory Affairs Manager role, do not hesitate to apply!

Apply now

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