Senior Regulatory Affairs Specialist – Medical Devices

Senior Regulatory Affairs Specialist – Medical Devices

Full-Time 63000 - 77000 Β£ / year (est.) On-site
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At a Glance

  • Tasks: Support regulatory submissions and audits for medical devices across US, EU, and Canada.
  • Company: Hologic, a leader in medical technology with a focus on innovation.
  • Benefits: Competitive salary, health benefits, and opportunities for professional growth.
  • Other info: Join a dynamic team dedicated to improving patient outcomes.
  • Why this job: Make a difference in healthcare by ensuring compliance and timely product approvals.
  • Qualifications: Experience in regulatory affairs and strong collaboration skills required.

The predicted salary is between 63000 - 77000 Β£ per year.

Hologic is seeking a Senior Regulatory Affairs Specialist to support regulatory submissions, audits, and product lifecycle activities for medical devices.

The role focuses on US, EU, and Canadian requirements and cross-functional collaboration with R&D, Quality, and Marketing teams.

You will manage regulatory documentation, labeling compliance, and unique device identification, ensuring inspection-ready records and timely product approvals.

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Senior Regulatory Affairs Specialist – Medical Devices employer: Hologic

Hologic, Inc. is an exceptional employer that prioritises innovation and employee development within the healthcare sector. With a strong focus on advancing women's health, employees are encouraged to grow their skills in a collaborative environment while making a meaningful impact in the lives of patients. The Central North territory offers a dynamic market landscape, providing unique opportunities for sales specialists to thrive and build lasting relationships with healthcare professionals.

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Contact Details:

Hologic Recruitment Team

We think you need these skills to ace Senior Regulatory Affairs Specialist – Medical Devices

Regulatory Submissions
Auditing Skills
Product Lifecycle Management
Knowledge of US Regulatory Requirements
Knowledge of EU Regulatory Requirements
Knowledge of Canadian Regulatory Requirements
Cross-Functional Collaboration