Massachusetts Jobs

Regulatory Affairs Specialist 3

San Diego, CA, United States

Marlborough, MA, United States

Job Summary

Responsible for regulatory compliance activities associated with commercialized products. A primary focus will be with post market requirements both domestic and international. This position requires a person with commitment to excellence, and ability to work in a fast-paced, technically skilled, team setting.

Essential Duties and Responsibilities

• 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.

Education & Experience

• 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.

Skills

• Demonstrated ability to coordinate complex projects.

• Strong oral and written communication and presentation skills

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

• Good analytical and problem solving skills.

• Demonstrate 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 international customers (e.g., regulatory agencies, distributors, etc.)Solid computer skills in Microsoft Office

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $89,900 to $119,500 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

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.

Must follow all applicable FDA regulations and ISO requirements.

Hologic is an equal opportunity employer inclusive of female, minority, disabled and veterans, (F/M/D/V)