Hologic Principal Regulatory Affairs Specialist in Marlborough, Massachusetts

Principal Regulatory Affairs Specialist

Post Date Jun 04, 2018

A Principal Regulatory Affairs Specialist provides regulatory support to cross functional teams working on a range of products in Hologic’s Breast and Skeletal Health Division that include breast screening equipment, breast biopsy and interventional devices, and treatment options. You will work in a multi-disciplinary group, contributing to the design, development and launch of Hologic’s innovative products that bring long-term positive change to patients and healthcare professionals.

Role

The Principal Regulatory Affairs Specialist provides medical device Regulatory Affairs expertise by participating in the day to day operations of the department as it relates to supporting business needs and new product introduction.

Essential Duties and Responsibilities

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Works with Regulatory Affairs Management to determine effective regulatory pathways for a variety of issues

  • Participates in cross-functional teams to implement the regulatory strategies for the timely support of project team goals

  • Ensures that product development projects and changes to existing products are conducted in compliance with the appropriate regulations

  • Participates in document review process by reviewing documents for regulatory compliance

  • Prepares FDA submissions, which may include: 510(k)s, IDEs, IDE Supplements, PMAs, PMA Supplements

  • Prepares Canadian medical device submissions

  • Prepares technical files/design dossiers for European CE mark

  • Interacts with regulatory bodies

  • Reviews and approves promotional material to assure compliance to Regulatory requirements

  • Complies with all Quality System requirements

  • Reviews technical publications, articles and abstracts to stay abreast of regulatory developments in the industry

  • May include other duties as defined by the Regulatory Affairs Manager

Qualifications

  • Excellent writing skills with ability to write detailed information for submissions

  • Excellent ability to read, analyze and interpret technical documents, professional journals, technical procedures and government regulations

  • Strong verbal skills including presentation skills

  • Strong interpersonal skills including the ability to interact with all levels of the company

  • Strong computer skills including Microsoft Office

Preferred Skills/ Qualifications

  • Excellent working knowledge of medical device regulations (21CFR) and FDA law

  • Solid working knowledge of the regulatory requirements related to European medical device directives

  • Capacity to communicate regulations to technical functions within the company

  • Ability to manage relationships with FDA

  • Experience with document control systems such as Agile and Oracle

  • Medical device software submission and validation experience highly desirable

Education

  • Bachelor’s degree (BA or BS) from a four year college or university in an engineering or science discipline (preferred)

Experience

  • Minimum of 7+ years’ experience in an FDA regulated industry preparing regulatory submissions for medical devices

Additional Details

  • There may be limited domestic travel

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.