Regulatory Affairs Specialist

Hologic•Marlborough, MA

4d•Hybrid

About The Position

At Hologic, women's health is at the heart of everything we do. Our Regulatory Affairs team plays a vital role in bringing innovative, compliant, and safe medical technologies to market, helping advance early detection, diagnosis, and treatment solutions that improve the lives of women around the world. Join Hologic’s Regulatory Affairs team and help shape the future of women’s health by navigating the path that transforms innovation into meaningful patient impact. This is a hybrid role working out of our Marlborough MA or San Diego office 3 days a week. Hologic is seeking a Regulatory Affairs Specialist responsible for assisting in the management of all regulatory activities within the defined country/geographical areas by performing the following under supervision of RA management or more senior RA personnel. This position requires a person with commitment to excellence, and ability to work in a fast-paced, technically skilled, team setting.

Requirements

Bachelor's Degree required in the life sciences or engineering with a minimum of 3 years direct experience in Regulatory Affairs (within a Medical Device / IVD industry preferred). or Master’s Degree and/or RAC with a minimum of 1 year direct experience in Regulatory Affairs within the Medical Device / IVD Industry
Solid working knowledge of the US and European medical device regulations
Demonstrated ability to coordinate complex projects
Capacity to communicate regulations to technical functions within the company
Experience with quality document control systems such as Agile and Oracle
Medical device software, including artificial intelligence, submission and validation experience desirable
Strong oral and written communication skills with ability to write detailed information for submissions
Good analytical and problem-solving skills
Proficient ability to read, analyze and interpret technical documents, professional journals, technical procedures and government regulations
Strong interpersonal skills including the ability to interact with all levels of the company
Ability to manage relationships with international customers (e.g., regulatory agencies, distributors, etc.)
Strong computer skills including Microsoft Windows, Microsoft Office Suite and Adobe Acrobat

Nice To Haves

Medical device software, including artificial intelligence, submission and validation experience desirable

Responsibilities

Provide general regulatory support for Cytology and Molecular instrumentation and software, including artificial intelligence devices
Support new product development activities, including cross-functional core team representation, pre-market submissions, and post-market submission authoring
Compile Technical Documentations for IVD medical devices to support EU CE-Marking
Collaborate with business partners to support ROW submissions for IVD medical devices (Asia Pacific, Latin America,Europe, the Middle East and Africa, Canada etc.)
Monitor progress on key project deliverables and provide status updates to management on a regular basis
Demonstrate in-depth understanding of advanced technical/scientific principles related to MDR / IVD reagent chemistry, laboratory automation, and software components of MDR / IVD medical devices
Conduct regulatory research and review of new regulations, laws, and regulatory agency guidances as they emerge.
Communicate regulatory requirements to technical functions within the company and assist teams in navigating regulatory interactions