Regulatory Affairs Specialist

Posted 24 January by PE Global

PEGlobal are looking for a Regulatory Affairs Specialist for our multinational medical devices client based in Scotland. 

Role profile: This role will be providing RA leadership for global regulatory affairs.

Main Responsibilities

  • Global Regulatory Environment
    • Individually researches as well as partners with in-country regulatory affiliates to monitor changing regulatory requirements.
    • Consolidates and communicates changes to global regulatory requirements to RA team and cross-functional business partners.
  • Global Product Registrations
    • Partners with RA Project leads to stay current on new product development and change projects and determine global filing strategies.
    • Partners with in-country regulatory affiliates to understand registration requirements for new product registration and lifecycle license maintenance (change registration, renewals) for existing products.
    • Consolidates global regulatory feedback and communicates requirements to change owners/project leads.
    • Provides documentation and product support to in-country regulatory affiliates for registration filings.
  • Assists in the development of best practices for Regulatory Affairs processes
  • Reviews and approves product labelling as required
    • Provides support for other regulatory activities as required

Desired Experience and Skillset of the Successful Candidate 

  • Significant Regulatory Affairs experience within the medical device industry with knowledge of IVD or MD regulations in US and/or EU (ideally compiling and submitting EU CE File and US 510(k) pre-market submissions)
  • Experience with global regulatory requirements and filings desired
  • Demonstrated understanding of Design Control;
  • Degree qualified, preferably in a scientific or technical field
  • Excellent verbal and written communication skills
  • Strong organizational, interpersonal, and problem solving skills; detail oriented
  • Ability to work independently and collaboratively with minimal supervision
  • Working knowledge of MS Office programs (Word, Excel, PowerPoint, Outlook) and electronic document management systems 

Reference: 34311379

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