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Associate Director Medical Devices Lifecycle Management

2 months ago

København, Denmark Internetwork Expert Full time

Want a 3D Career? Join Norgine.

At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.

We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.

Bring everything about yourself that you’re proud of, whether that’s your passion for making a difference, focus on others’ well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.

In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people’s wellness as much as you do.

Because at Norgine, we transform lives with innovative healthcare solutions.

We have an exciting opportunity for an Associate Director Medical Devices Lifecycle Management to join Norgine. The person holding this position will report to the Director Regulatory Lifecycle Management and be a member of the Regulatory team.

The Associate Director Medical Devices Lifecycle Management is responsible for the strategic lifecycle management of Norgine’s Medical Devices 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 ongoing regulatory maintenance activities.

Key responsibilities include but are not limited to:

  1. To be the primary regulatory point of contact for all medical device queries for Norgine 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 devices
  • anticipating and resolving complex regulatory issues associated with medical devices
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
  • Resolution of roadblocks, escalation of issues through effective communication
To represent Regulatory Affairs Lifecycle Management – Medical Devices internally and externally To manage own workload, including responsible delegation, to ensure agreed regulatory activities are planned, agreed and progressed 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 explore opportunities for continuous improvement to enhance business performance To maintain data and documentation in compliance with Norgine’s regulatory systems and procedures To participate in industry forums To ensure adherence to compliance policies

Minimum Requirements:

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