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Senior Regulatory Affairs Specialist

Newark, DE, United States

Marlborough, MA, United States

Join us as a Regulatory Affairs Specialist—Sustaining, and play a pivotal role in supporting and improving mature products and processes.

About the Role:

As a key member of our Regulatory Affairs team, you will be responsible for the ongoing support, maintenance, and continuous improvement of regulatory compliance for our capital equipment medical device portfolio. Working cross-functionally with R&D, Quality, Clinical, and Marketing, you will prepare and manage regulatory submissions, technical files, and documentation to meet US, EU, and Canadian requirements. You will provide expertise in sustaining work, supporting product changes, labeling updates, and regulatory process enhancements for both established and evolving products. We are open to the Newark, DE or Marlborough, MA with a hybrid schedule.

What You’ll Do:

+ Prepare, compile, and maintain regulatory document packages for submissions, license renewals, audits, and inspections for capital equipment medical devices

+ Review and update labeling, marketing materials, and user manuals to ensure compliance with all applicable regulations and company policies

+ Monitor and interpret regulatory procedures and changes, proactively updating documentation and processes as needed

+ Partner with cross-functional teams to support product changes and ensure regulatory requirements continue to be met throughout the product lifecycle

+ Participate in internal and external audits, regulatory inspections, and investigations, providing high-level regulatory support and guidance

+ Maintain and improve regulatory databases, tracking, and control systems

+ Recommend and implement process improvements to streamline regulatory workflows and documentation practices

+ Keep abreast of evolving medical device regulations and industry standards, sharing knowledge and best practices across the team

What We’re Looking For:

+ Bachelor’s degree in a technical or scientific discipline (Master’s or RAC certification preferred)

+ 5–8 years’ regulatory affairs experience in the medical device industry, ideally with capital equipment products

+ Proven expertise preparing and maintaining regulatory submissions and technical files for mature and evolving products (US, EU, and Canada)

+ Strong understanding of relevant regulations and standards (FDA, ISO 13485, ISO 9001)

+ Experience supporting audits, inspections, and cross-functional project teams

+ High attention to detail, strong technical writing, and excellent communication skills

+ Proactive, solutions-oriented mindset with a passion for continuous improvement in compliance processes

+ Proficiency with MS Office and regulatory document management systems

+ Experience with capital equipment (preferred)

+ Project management experience and Regulatory Affairs Certification (RAC) are assets

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 $90,500 - $141,600 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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