Hologic Senior Regulatory Affairs Specialist in Marlborough, Massachusetts
Senior Regulatory Affairs Specialist
Post Date Oct 11, 2018
At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health
What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.
None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.
While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.
A Senior Regulatory Affairs Specialist provides global Regulatory support to cross functional teams working on a range of products in Hologic’s GYN Surgical Solutions Division that include radiofrequency impedance-based technology, fluid movement, and electronics. 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 Senior 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.
Essential Duties & 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
Supports international registration activities
Interacts with domestic and international regulatory bodies and distributors
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 Regulatory Affairs Management
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; additional experience with international registration requirements highly desirable
Capacity to communicate regulations to technical functions within the company
Ability to manage relationships with FDA and international customers (e.g., regulatory agencies, distributors, etc.)
Experience with document control systems such as Agile and Oracle
Medical device software submission and validation experience highly desirable
Certified regulatory affairs professional highly desirable
- Bachelor’s degree (BA or BS) from a four year college or university in an engineering or science discipline (preferred)
- Minimum of 5+ years’ experience in an FDA regulated industry preparing regulatory submissions for medical devices
- There may be limited domestic or international 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 & VEVRAA Federal Contractor