Regulatory Affairs Specialist

Regulatory Affairs Specialist Marlborough, MA, United States San Diego, CA, United States 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. Job Summary 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. 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 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 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 job. Lifting/pushing/pulling and carrying products weighing up to 45 pounds Potential Exposure to moving mechanical parts, vibration and/or moderate noise levels. Potential Exposure to hazardous chemicals or other materials. Safety Shoes compliant with site specific policies/procedures must be worn in designated areas Qualifications Education & Experience 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 Skills 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 The annualized base salary range for this role is $73,000- $114,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Hologic is an equal opportunity employer and consistent with federal, state, and local requirements, will consider requests for reasonable accommodation based on disability or sincerely-held religious beliefs where it is able to do so without undue hardship to the company. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #J-18808-Ljbffr Hologic, Inc.