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Job Title:  Lead Regulatory Affairs Specialist

Req ID:  32347
Job Category:  Regulatory Affairs

Leicester, LCE, GB, LE7 1PF

Description: 

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

the incumbent is responsible for supporting the development and administration of STERIS’s global regulatory policy positions across product lines of the STERIS businesses by preparing international regulatory submissions for STERIS 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. 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 STERIS's business. Responsible for keeping abreast of and providing regular reporting to key business leaders on key regulatory developments that impact customers, or STERIS’s business directly.

 

Duties

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

*Become expert in the new EU Medical Device Regulations and provide key support for compliance to this.

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

*Support Manager, Regulatory Affairs with all regulatory matters.

*Keep abreast of multiple regulatory issues that impact STERIS, including local and 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 STERIS's positions.

*Work with 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 Regulatory management.

Duties - cont'd

*Track pending registrations and actions required to complete registration activities in a timely manner.  Follow up with in-country Dealers and/or Consultants as needed to ensure completion of necessary actions.

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

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

*Support RA compliance activities as necessary in assigned regions.

*Coach RA Specialist registration activities

Education Degree

  • Bachelor's Degree in Science

Required Experience

*A bachelor’s degree is preferred (with Science background),  or equivalent years of regulatory/registrations experience and some level of college course work.

*Minimum 6-7 years’ previous government relations and regulatory experience.

*Must possess a strong cultural awareness and sensitivity when working with International government officials

*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 Business Unit team coordination, planning, research, diplomacy, and advocacy 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.

In some cases, supervision of Specialist level positions or interns may be possible.

Preferred Experience

Skills

*Autonomous and self-starter

*Capability to interact effectively and credibly at senior levels.

*Must have the ability to build relationships and influence decision makers.

 

STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer.  

Req ID:  32347
Job Category:  Regulatory Affairs

Leicester, LCE, GB, LE7 1PF


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