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Hologic Regulatory Affairs Specialist 3 in San Diego, California

Regulatory Affairs Specialist 3

San Diego, CA, United States

As a leading innovator of women’s health, we at Hologic are empowering people to live healthier lives everywhere, every day.

Our Quality and Regulatory Affairs team is responsible for keeping abreast of new, changing, and existing regulatory requirements. They lead the development and implementation of a global vision for regulatory affairs, government relations, quality management, and market access, to influence strategic and operational plans.

We are hiring for a Regulatory Affairs Specialist 3, responsible for international regulatory activities and post-market regulatory submissions. If you are an experienced Regulatory Affairs Specialist experienced in IVD or Drug/Biologics industry, and committed to excellence in a fast-paced environment, read on!

What you are signing up for:

  • Assess manufacturing changes for reporting changes to global regulatory agencies.

  • Prepare, compile, and publish electronic post-market regulatory submissions.

  • Compile Technical Documentation for IVD medical devices to support EU IVDR CE-Mark and other annual support activities to maintain CE-Mark requirements.

  • Interact with business partners to support ROW submissions for IVD medical devices (Asia PAC, Mexico, Brazil, Canada, etc.).

  • Develop and execute submission strategies for assigned projects.

  • Review of product labeling, literature, and Web site for accuracy, consistency, and regulatory compliance

  • Develop and/or revise regulatory procedures

  • Support US PMA and Canadian annual reports, Canadian post-market surveillance reports, and other required post-market reports.

What we are looking for:

  • Bachelor's Degree required in the life sciences or engineering with a minimum of 5-8 years direct experience in Regulatory Affairs within an IVD or Drug/Biologics Industry. International experience preferred.

  • Master’s Degree and/or RAC preferred with a minimum of 3-5 years direct experience in Regulatory Affairs within an IVD or Drug/Biologics Industry.

  • Solid working knowledge of the US Regulations and European IVD and medical device directives

  • Demonstration of in-depth understanding of advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.

  • Experience with International submissions and IVDs highly desirable

  • Capacity to communicate regulations to technical functions within the company

  • Ability to manage relationships with international customers (e.g., regulatory agencies, distributors, etc.)

Interested to find out more? Apply now!

#LI-RF1

Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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