Regulatory Manager

Posted 18 November 2021
Job type Permanent
DisciplineLife Sciences & Engineering Technologies, Science Leaders & Specialists
ContactMaeve Fahey

Job description

HRM have been retained by a global Medical Devices leader, are dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. They are seeking an experienced Regulatory Manager to join a high-performing and established Regulatory team at their state-of-the-art manufacturing campus in Tipperary. Hybrid working model available.

The Role

Duties and responsibilities of the Regulatory Manager will include but are not limited to:

  • Management of regulatory activities at the site including providing information to US based Regulatory Affairs groups for OUS and US submission activities.
  • Taking responsibility for regulatory activities related to new product manufacturing as well as management of regulatory issues relating to manufacturing changes or field corrections. Key point of contact for all regulatory queries.
  • Management and development of site Regulatory function and personnel and prioritization of workload to support business needs.
  • Manage departmental procedure development and implementation including assessing the impact of worldwide internal and external regulatory changes on existing processes and procedures.
  • Prepare/assist in preparation of Design Dossiers and PMA Submissions for products, in conjunction with divisional regulatory personnel.
  • Management of timely assessment of all product and manufacturing changes for compliance to applicable company requirements and external regulations.
  • Develop regulatory strategies for existing and new product introduction including delivery of continuous improvement projects for the Regulatory process.
  • Support worldwide Regulatory requests for regulatory agency submissions by the timely collation and provision of site date.
  • Site Regulatory representative at global BSC Quality System communities of practice where required.
  • Establish and support a work environment of continuous improvement that supports Quality policy, Quality System & the appropriate regulations for the area.

The Person

You will have skills and experience in the following:

  • BSc and 5+ years relevant industry experience, medical devices preferred
  • Supervisory / leadership experience is essential
  • Working knowledge of FDA, EU and international medical device regulations
  • Experience working with Class III devices would be an advantage
  • Strong communicator and ability to work cross-functionally
  • Experience working with global teams would be beneficial
  • Excellent collaboration skills to optimise the relationship with internal and external partners.

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 632 1885 for a confidential discussion.