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.
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
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
- Bachelor’s degree (BA or BS) from a four year college or university in an engineering or science discipline (preferred)
- Minimum of 7+ years’ experience in an FDA regulated industry preparing regulatory submissions for medical devices
- 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.