Company: Mosaic Regulatory Solutions
Closing Date: 29 Dec 16
Salary (£): On Application
Benefits: Excellent + Bonus + Bens
To apply for this regulatory affairs specialist role please call Julie Cooper on 07951 082482 or alternatively please send your CV to :email@example.com in the strictest confidence.
Role: Lead Regulatory Affairs Specialist
Salary - Negotiable
Reporting to the EMEA Manager, Regulatory Affairs within the RA Department, the incumbent would be responsible for supporting the development and administration of global regulatory policy positions across product lines of the businesses by preparing international regulatory submissions for the full range of consumables 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.
ESSENTIAL JOB FUNCTIONS
*Expert in EU chemicals legislation including BPR, REACH, CLP & Detergents and primary specialist responsible for registrations for products governed by these regulations. Also knowledgeable in medical device regulations.
*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.
*Monitors current projects and pending and planned submissions to track timelines, identifies any unexpected delays, and communicates progress on projects and submissions to business partners.
*Maintains paper and electronic submission documents, shared drive folders, and databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information.
*Consolidates information and documentation on proposed, newly acquired, or modified products to correctly determine product classification and submission and medical device/biocide listing requirements.
*Synthesizes and actively supports Regulatory Affairs management’s Regulatory Strategy and accurately communicates it to business partners throughout the project. Engages Regulatory management as necessary when changes occur or new risks or requirements are identified, and propose actions as appropriate.
*When serving as Regulatory advisor on product development team, acts as champion for compliance with design controls, good documentation practices, and risk management standards. Reviews documents carefully to ensure that user needs are clearly identified and required testing is planned to support the indications for use desired.
*Generates clear and concise checklists for product development team use to ensure completion of requirements.
*In the role of Regulatory Representative, applies regulatory knowledge and judgment to identify compliance concerns and formulate potential remediation activities. Gathers and presents sufficient information to facilitate Regulatory Affairs management appraisal of any proposed device modifications, or for resolution of compliance issues.
*In the role of Regulatory Representative, stays abreast of the facility’s open CAPAs, ongoing audits and non-conformance citations, recall activities, and general FDA inspection preparedness. Through Management Review and other interactions, keep facility staff informed of changes in regulations or international standards that may affect their products.
*When assigned to support Due Diligence & Integration, applies Regulatory and Quality Systems knowledge and procedural guidance to perform appropriate inquiry and investigation, understand and analyze the information acquired, synthesize a workable approach to integration including risk remediation as needed, and provide guidance throughout the integration process to execute the plan.
*Review and approve labeling and marketing literature.
*Support EMEA Manager, Regulatory Affairs 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 EMEA Manager, Regulatory Affairs 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.
General office environment conditions. Position may require occasional (10%) local, domestic or international travel to facilities, government agencies, Customers, trade shows or training courses.
*A bachelor’s degree, and preferably post graduate work (JD or MBA).
*Minimum 5-8 years previous government relations and regulatory experience.
*Government agency and/or legislative experience required
*Must have the ability to build relationships and influence decision makers.
*Capability to interact effectively and credibly at senior levels.
*Extensive understanding of chemical/ medical device industry, in particular the workings of the regulatory and legislative environment around the world.
*Comprehension of industry developments and changes in the political environment.
*Extensive network-building and contact experience.
*Demonstrated excellence in the following: communications skill, listening skills, interpersonal skills, cross BU team coordination, planning, research, diplomacy, advocacy and sales skills.
*Ability to operate in a business driven model providing quick, salient analysis and concrete action plans emphasis on understanding and anticipating business needs and interests and devising proactive approaches/responses.
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Mosaic Regulatory Solutions Ltd
|Tel:||0208 305 9733|
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