At Hologic womens 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 Hologics Regulatory Affairs team and help shape the future of womens 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.
Job Summary
Hologic is seeking aRegulatory Affairs Specialistresponsiblefor assisting in the management of all regulatory activities within the defined countrygeographical 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.
Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
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 AmericaEurope 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 technicalscientific 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
Physical Demands
The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this