Associate Director, Regulatory Affairs

Job Title: Associate Director, Regulatory Affairs -  Medical Device/ Post Market Surveillance

Job Type: Full Time, Permanent Position

Locations:  Italy (Milan) – Hybrid

Remuneration: Attractive salary and package

An exciting opportunity to join a growing pharmaceutical company that specialises in Cancer and Supportive Care, Gastroenterology and Hepatology. Due to increasing growth the business is looking for an Associate Director, Regulatory Affairs Medical Device Lifecycle Management to join the team.

As an Associate Director, Regulatory Affairs - Medical Devices Lifecycle Management you will be responsible for the strategic lifecycle management of the businesses Medical Device post CE approval and the operational execution management with the Regulatory Service Provider. This includes the responsibility and oversight of all activities required for the successful and smooth integration of new products following launch and all associated on-going regulatory maintenance activities.

Main Responsibilities:

·       To be the primary regulatory point of contact for all medical device queries for the businesses portfolio by providing guidance on regulatory medical device requirements and compliance to brand teams and other areas of the business.

·       Inputting into discussions on projects and questions associated with medical device anticipating and resolving complex regulatory issues associated with medical devices.

·       Lead an support all post market surveillance activities for the medical device portfolio in the UK, Europe and growth regions.

·       Drive all Regulatory Affairs Medical Device strategies for a global regions.

·       To oversee, manage and where required advise the Regulatory Service Provider on medical device maintenance and submission strategies, plans and the preparation of updates to the technical file and regulatory submissions for all medical device related changes.

·       The preparation of high quality documentation for labelling regulatory submissions, following current best practice.

·       To represent Regulatory Affairs Lifecycle Management – Medical Devices internally and externally

·       To maintain up to date knowledge of relevant regulations, guidelines and industry standards and apply in practice through procedures, knowledge sharing and advice to project teams.

·       To manage regulatory intelligence information for medical devices including databases (e.g. NOTIS).

·       To co-ordinate QMS related regulatory activities e.g. deviations and CAPAs as applicable.

·       To manage own workload, including responsible delegation, to ensure agreed regulatory activities are planned, agreed and progressed.

Requirements:

·       BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience.

·       Previous experience in Regulatory Affairs is a MUST!

·       At least 8 years + experience within the medical device sector and have a sound understand of new registrations and post market surveillance activities.

·       Confident with maintaining medical devices in global regions.

·       Broad regulatory medical device experience, part of which should have been gained operating at a senior level, and good knowledge of worldwide regulatory requirements (including GMP, GLP and BCP).

·       Must have expertise in the development, certification and maintenance of medical device products.

·       Line management or staff oversight/ coaching experience.

·       Experience managing Service Providers is essential.

This role allows the right person to step into a senior role within the business and take responsibility for a growing portfolio of medical devices. Due to the businesses continuous growth this person will have an excellent opportunity to growth and develop. The position also comes with an attractive salary and package.

For more information regarding this role please reach out to lucy.kirkaldy@cpl.com

Please note you must have the full right to work and this employer doesn’t offer sponsorship.