Regulatory Affairs Specialist
OrionGroup are looking for a Regulatory Affairs Specialist for our multinational lifesciences client based in the Highlands of Scotland on an initial 12 month contract.Role profile: This role will be providing RA leadership for global regulatory affairs.Main Responsibilities of the role:* 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 requiredDesired Skillset and Background 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 systemsOur role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment