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Manager, Global Regulatory Affairs

Marlborough, MA, United States

The Manager, Global Regulatory Affairs will support leadership, ensuring alignment, consistency, and excellence in regulatory practices. This role will execute in the development and implementation of global regulatory systems, support regulatory process harmonization efforts and projects, and support regulatory intelligence and training initiatives.

The ideal candidate is a collaborative leader with deep regulatory knowledge, strong communication skills and the ability to operate effectively in a matrixed, global organization.

Builds and maintains relationships within the Regulatory Affairs functional areas, Operations, Quality, and Research & Development (R&D) organizations.

Essential Duties and Responsibilities

+ Contributes to the development of training, tools, and resources to build global regulatory capabilities.

+ Manage the implementation, governance, and optimization of a RIMS platform to ensure consistent data management, submission tracking and regulatory reporting.

+ Support harmonization efforts to align global regulatory processes, SOPs, and best practices across the business.

+ Support global regulatory intelligence capabilities that monitor and interpret emerging global regulations and trends.

+ Partner with cross- functional stakeholders including Quality, Clinical, Legal and Product Development on key initiatives.

+ Support global labeling initiatives including systems, processes and procedures to streamline and enhance efficiency.

+ Promote a culture of compliance, collaboration and continuous improvement within the regulatory function.

Qualifications

Education & Experience

+ Minimum of bachelor’s degree in a science related field preferred.

+ A minimum of 8 years of experience in Regulatory Affairs within the Medical Device industry.

+ Experience authoring/supporting/maintaining SOPs.

+ Deep understanding of global medical device and/or IVD regulations.

+ Experience managing projects in a matrixed environment is preferred.

Skills

+ Effective communicator and relationship-builder across technical and management teams.

+ Proactive, adaptable, and solution-oriented mindset.

+ Strategic thinker with the ability to simplify complex challenges.

+ Ability to manage small to mid-sized projects with some complexity.

+ Demonstrated proficiency working within a QMS.

+ Firm understanding of regulatory challenges in the medical device or IVD space.

+ Solid computer skills in Microsoft Office programs (i.e. Word, Excel, Project)

Why join Hologic?

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $113,700 to $189,400 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 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.

_Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans._

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