This is a hybrid role working out of our Marlborough MA or San Diego office 3 days a week.Job SummaryHologic 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 ResponsibilitiesThe 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 DemandsThe 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.
Agency And Third-Party Recruiter NoticeAgencies 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.
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