Hologic Regulatory Affairs Specialist in Marlborough, Massachusetts
Regulatory Affairs Specialist
Post Date Aug 14, 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.
The Regulatory Affairs Specialist will prepare and submit regulatory documents to appropriate global regulatory authorities. Submit and follow-up on product changes with global regulatory authorities. Submit paperwork to new countries for registration of product worldwide.
Essential Duties & Responsibilities
Respond to written questions form regulatory agencies as necessary.
Submit and follow-up on approval for product changes with regulatory agencies.
Maintain regulatory files for International submissions/documents.
Interpret existing or new international regulatory guidelines as they relate to company products, procedures, and policies.
Prepare/revise regulatory procedures as required.
Provide input to project teams to assure regulatory authority requirements are incorporated as part of the product development process.
Assist with international product registrations.
Retrieve guidelines and other regulatory information from the internet and other appropriate sources
Attend appropriate regulatory meetings and maintain update on regulatory changes.
Interact with outside agencies such as international legal authorities, legal counsel, and other consultants.
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.
Excellent written and verbal communication skills
Very proficient in attention to detail
Excellent organizational skills
Good negotiation and interpersonal skills
Experience using Microsoft Office (Excel and Word)
Experience using Information Mapping software preferred
- Minimum BA/BS preferable
2+ Years experience in Regulatory Affairs Specialized Knowledge
Experience with Technical Files, Design Dossiers, Canadian registration, and worldwide registrations
General understanding of worldwide medical device regulations and regulated environment
Experience working in a medical device GMP/ISO medical device manufacturing environment
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.