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Rockbridge Search & Recruitment 13/09/2021

Regulatory Affairs Manager

Ref #: 401
Location: Washington Washington 98225
Salary: $125k-$150k
Sector: Life Sciences
Type: Permanent
  • Supporting the cross functional teams with regulatory guidance during all design control phases of a new product or major changes
  • Directly responsible for the coordination and preparation of document packages for regulatory submissions
  • Responsible for the coordination and preparation of document packages for technical file and design dossiers for CE marking, domestic registrations, and support worldwide product registrations per in-country regulations
  • Involved in developing, modifying, and executing company regulatory policies that affect immediate operations
  • Recommend and develop strategies and create detailed written regulatory plans
  • Identify potential regulatory approvals risks based on changes in regulations, standards, country specific issues or other unique characteristics of the project
  • Drive improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System. Review and recommend changes for design process and manufacturing procedures to maintain quality and regulatory compliance
  • Responsible for ensuring compliance with regulatory procedures and updating the procedures when new regulatory requirements become effective
  • Advise internal stakeholders regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives
  • Review and approve advertising, promotional items and labeling for regulatory compliance
  • Bachelor’s degree in a technical/healthcare/business discipline or equivalent
  • 5+ years of relevant experience in a medical device company (FDA Class II)
  • 5+ years of experience with successful preparation and submission of 510(k)s and a proven track record of success with the FDA
  • Excellent English skills (written and oral)
  • Certified regulatory affairs professional would be desirable