Regulatory Affairs Specialist, International

Join Our Team: Regulatory Affairs Specialist – Surgical Division

Are you ready to make a real impact in healthcare innovation? As a Regulatory Affairs Specialist supporting our dynamic Surgical division at Hologic, you’ll play a vital role in bringing life-changing medical devices to market—both in the U.S. and around the world.

In this role, you’ll coordinate and prepare document packages for regulatory submissions, audits, and inspections—ensuring both new and established products meet rigorous US, EU, Canadian, and global regulatory standards. You’ll collaborate with talented cross-functional teams to drive product launches, implement changes, and support international registrations, all while maintaining precise and up-to-date regulatory documentation.

This is your opportunity to help shape the future of surgical technologies, working alongside passionate professionals dedicated to improving patient outcomes worldwide.

Key Responsibilities:

• Prepare and compile document packages for regulatory submissions, audits, and inspections for both domestic and international markets.
• Maintain regulatory databases and technical files to support global product registrations.
• Review labeling, marketing materials, and user manuals for compliance with US and international regulatory requirements.
• Identify and recommend changes for labeling, manufacturing, marketing, and clinical protocols.
• Participate in design reviews and develop regulatory strategies for product approvals in multiple geographies.
• Support cross-functional teams and process improvement initiatives, collaborating with global colleagues.
• Stay current with existing and emerging regulations, standards, and laws in all markets where we operate.
  
  

Skills & Expertise:

• Strong written, verbal, and interpersonal communication skills.
• High attention to detail and accuracy in documentation.
• Excellent technology proficiency (MS Office, document storage systems).
• Knowledge of ISO 13485, ISO 9001, FDA, and foreign (EU, Canada, etc.) regulatory requirements.
• Understanding of data/statistical analysis.
• Regulatory Affairs Certification (RAC) and project management experience a plus.
  
  

What You’ll Need:

• Analytical thinking and sound judgment within defined procedures.
• Collaborative mindset—works productively across internal and external, global teams.
• Proactive approach to identifying and resolving compliance issues.
• Commitment to continuous learning and professional development.
  
  

Qualifications:

• Bachelor’s degree in a technical field preferred.
• 2–5 years' experience in regulatory affairs (medical device industry).
• Experience with technical documentation and regulatory databases.
  
  

Physical Demands & Travel:

• Primarily office-based work (sitting, computer use).
• Limited travel as necessary (up to 10%)
  
  

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. 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. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!

The annualized base salary range for this role is $72,100 - $112,800 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.

LI-#DS1