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.
- 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