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Job Title:  Lead Regulatory Affairs Specialist

Req ID:  19054
Job Category:  Regulatory Affairs
Country/Region:  US
State:  MO
City:  St. Louis
Zip:  63133
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 Lead Regulatory Affairs Specialist 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 medical device, biocide and chemical 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. 

What You Will Do

•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 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 the Regulatory Affairs Manager 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.
•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.

What You Need to be Successful

•Bachelor’s Degree plus a minimum of 3 years of relevant experience or a minimum of 8 years of relevant experience in lieu of a degree required
•Experience in preparing US and/or International registration dossiers 
•Experience in securing Free Sale Certificates and Export Certificates
•Experience in working with Dealers, Distributors and consultants to establish registration requirements 
•Working with tracking databases to manage registration activities
•Reviewing regulations and interpreting for providing guidance to Business Units
•Experience working with R&D and Operations staff in securing documentation in support of RA submissions 

 

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Offering You in Return

The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid-time off, holidays, matching 401(k), annual merit, and incentive plans.  Join us and help write our next chapter.

 

STERIS strives to be an Equal Opportunity Employer.  


Nearest Major Market: St Louis

Job Segment: Medical, Product Development, Medical Device, Healthcare, Research