Regulatory Affairs Specialist, Medical Device

Hologic • Louisville, CO

129d • $72,100 - $112,800

About The Position

Join Hologic's Surgical Division as a Regulatory Affairs Specialist. Are you detail-oriented, collaborative, and passionate about bringing innovative medical devices to market? Hologic's Surgical division is seeking a Regulatory Affairs Specialist to drive global product commercialization, support New Product Development (NPD), and ensure continued market access for our cutting-edge surgical technologies.

Requirements

• 2-5 years in regulatory affairs, preferably within the medical device industry.
• Proven experience preparing regulatory documentation and supporting product release processes.
• Hands-on experience supporting New Product Development and managing the regulatory design life cycle.
• Strong written, verbal, and interpersonal communication abilities.
• Proficiency with technology applications such as MS Office.
• Knowledge of document storage systems and technical file creation.
• Understanding of ISO 13485, ISO 9001, FDA, and international regulatory requirements.
• Data and statistical analysis capabilities.
• Impeccable attention to detail.

Nice To Haves

• Regulatory Affairs Certification (RAC) and project management experience are a plus.
• Master's degree.

Responsibilities

• Coordinate and prepare document packages for regulatory submissions, audits, and inspections for both new and established products.
• Compile materials required for submissions, license renewals, and annual registrations.
• Monitor and enhance tracking and control systems to support product releases and ongoing compliance.
• Review labeling, marketing materials, and user manuals to ensure alignment with regulatory requirements.
• Recommend updates to labeling, manufacturing, marketing, and clinical protocols for regulatory compliance.
• Collaborate with cross-functional teams—including R D, Clinical, Quality, and Marketing—participating in design reviews and developing regulatory strategies for product approvals.
• Actively support NPD projects and manage the regulatory aspects of the full design life cycle, from concept through commercialization and post-market changes.
• Help develop and refine processes, procedures, and standards to meet internal SOPs and industry regulations.
• Stay current with the latest regulations, standards, and laws impacting the medical device industry.

Benefits

• Competitive salary and annual bonus scheme.
• Comprehensive training upon joining and continued development throughout your career.

What This Job Offers

• Job Type: Full-time
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree