Job DescriptionRegulatory Affairs Specialist manages assigned projects of moderate complexity which include international regulatory activities; on-market compliance reports or assessment of design changes, manufacturing process and labeling changes for regulatory reporting, as assigned. 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- Participate in product development project teams which include new or existing products as the regulatory representative and provide guidance on global regulatory requirements for new/existing products
- Assess manufacturing process, design, and labeling changes regulatory assessments and global change management for manufacturing changes associated with the Cytology and Molecular product lines.
- Prepare and maintain international submission dossiers
- Prepare, compile and publish post-market regulatory submissions
- Compile and / or maintain Technical Documentations for IVD medical devices to support EU CE-Mark
- Interact 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.
- Review validation, clinical/R&D protocols and reports to be included or summarized in regulatory submissions
- Interface with product development teams/sustaining teams and regulatory authorities throughout the product lifecycle
- Provide recommendations for compliant advertising/promotional materials
- Keep informed of new and revised regulations; disseminate information as appropriate.
- Manage relationships with international customers (e.g., regulatory agencies, distributors, etc.)
- 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
- Prepare/manage internal procedures for continuous process improvement. Provide guidance on new or revised procedures and policies (as assigned).
Qualifications Education & Experience - Bachelor's Degree required in the life sciences or engineering with a minimum of 4 years direct experience in Regulatory Affairs (within an MDR / IVD industry preferred).
- Master's Degree and/or RAC with a minimum of 1 year direct experience in Regulatory Affairs within the MDR / IVD Industry
Skills- Demonstrated ability to coordinate complex projects.
- Understanding of medical device and IVD regulations in US and international markets.
- Capacity to communicate regulations to technical functions within the company
- Understanding of product life cycle process, design control and/or risk management.
- Experience with document control systems such as Agile and Oracle
- Ability to work independently and effectively
- Strong oral and written communication skills with ability to write detailed information for submissions
- Good analytical and problem solving skills.
- Ability to make and keep time bound commitments for project completion
- 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 international customers (e.g., regulatory agencies, distributors, etc.)
- Strong computer skills including Microsoft Office
The annualized base salary range for this role is $74,100 - $116,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
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.
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