Senior Regulatory Affairs Specialist- Remote based role- Medical Devices - 9 months FTC Mat Cover

TITLE: Senior Regulatory Affairs Specialist

Location - Remote / Home Based

Duration - Maternity cover for 12 months 

Salary- On application ( Annual Salary Pro Rata and Bens )

DEPARTMENT: Regulatory Affairs     

REPORTS TO:   Director Regulatory & Quality Compliance

Reporting to the Director Regulatory & Quality Compliance within the RA Department, the incumbent would be responsible for supporting the development and administration of the global regulatory policy positions across product lines of the  businesses by preparing international regulatory submissions for  the full range of  product approvals. This responsibility includes working independently with Marketing, Product Development, Consultants and Dealers to consolidate information and documentation required for regulatory filings in numerous countries within EMEA. The Incumbent will also provide support for plans to achieve identified corporate regulatory policy objectives. Also develops related strategies and tactics to achieve stated business unit objectives subject to regulatory authority oversight which affects  business. Responsible for keeping abreast of and providing regular reporting to key business leaders on key regulatory developments that impact customers, or business directly.

*Identify regulatory requirements for new products or product enhancements early in the product development cycle.

*Gather information to support regulatory submissions.  Use this information to prepare regulatory submissions in a complete, thorough format to support  product claims.

*Review product revision requests to assure compliance with regulatory requirements.

*Work on product teams to develop regulatory strategy based on regulatory submission requirements.

*Review and approve labeling and marketing literature.

*Support Director Regulatory & Quality Compliance with all regulatory matters.

*Keep abreast of multiple regulatory issues that impact  including EU, national requirements and translate the impact of these on the business.

*Establish and leverage working relationships with government, regulatory agencies, and trade associations for the purpose of advocating  positions.

*Work with Director Regulatory & Quality Compliance and senior internal stakeholders to identify key initiatives, which may be affected by present or emerging policies. As part of this, develop and recommend government affairs policy positions to upper management.

*Initiate and maintains internal information exchange channels, for example, manage regulatory support for  regional legislative and regulatory groups.

*Prepare and/or review written materials for substance and/or policy consistency.

*Act as spokesperson, when appropriate, regarding  practices, public policy, business interests; arrange for technical explanations from internal or external experts.

*Support RA compliance activities as necessary in assigned regions.

*A bachelors degree, and preferably post graduate work (JD or MBA).

*Minimum 3-6 years previous government relations and regulatory experience.