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Job Title:  Regulatory Affairs Manager

Req ID:  19114
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 mission of the International Regulatory Affairs group is to implement effective processes to obtain and maintain product registration approvals to market STERIS products in designated countries in support of STERIS’s global business plans. This includes determining registration and submission requirements in the various markets and identifying the documentation needed to meet the identified registration requirements. 


The Regulatory Affairs Manager has primary responsibility for the effective management of the functional areas, including the training, utilization and supervision of US Regulatory Affairs staff.  This role will works closely with Business Unit partners, STERIS Corporate Regulatory Affairs domestic staff, STERIS distributors, regulatory consultant contractors and various U.S. and foreign government agencies to prepare and submit required documents. 
 

What You Will Do

•Sets goals, guides project activities, tracks progress, reports status as appropriate, and takes action on unexpected setbacks to avoid delays, late filings, or disruption in product availability.
•Identify and keep current with the various domestic and international country submission/registration/approval and compliance requirements for marketing STERIS products domestically and in 50+ countries outside the U.S.A. where STERIS does business. 
•Effectively interface with government agencies, consultants and authorized dealer representatives as necessary to address registration related issues.
•Provide regulatory guidance and support to project teams and STERIS internal Customers to support new product development and existing product lines in support of registration requirements.
•Develop sound global regulatory strategies for new products.  Identify and communicate applicable regulatory requirements to STERIS Regulatory Affairs management and the department’s business partners from the start of product development through qualification testing and submission/registration, and as changes occur or new requirements are identified.  
•Gather information and documentation on new or modified products to determine submission requirements for particular markets.  Compile and create document registration packages through analysis and synthesis in a standardized format to support product claims and satisfy regulatory authorities.  Critically assess the strength and completeness of documentation created by others; advise improvements to comply with current requirements for particular regulatory authorities. 
•See that all staff members maintain paper and electronic submission documents and databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information. 
•Report to management concerning current, pending, and re-registration approvals.  Identify and take action on any unexpected delays; initiate re-registrations in a timely manner to avoid disruption in product availability.  
•Review and approve product labeling to ensure that all label formats, product claims and instructions for use are appropriate and cleared indications for use.
•When assigned role of Regulatory Representative, apply regulatory knowledge and judgment to the evaluation of product modifications, communicate potential regulatory compliance issues, and assist the facility in addressing regulatory issues in a timely manner.  Responsibilities include gathering core information from manufacturing, quality, etc. to assess the significance of a proposed product change and, when applicable, forwarding the information to Regulatory Affairs management for review under the Regulatory Affairs Product Change Review committee.
•Responsible for maintaining understanding of and compliance with all current active Corporate Procedures applicable to his/her job functions.
•Maintain conduct in accordance with the principles of the STERIS Code of Business Conduct and comply with all Company policies.
•Protect company confidential information by properly storing, retrieving and disseminating such information only to those authorized.
 

What You Need to be Successful

•Bachelor’s Degree required, preferably with scientific, engineering, regulatory, internal audit, pre-medical, legal, or general business core concentration.  
•Minimum of 7 years of professional experience required, preferably including regulatory affairs, legal or governmental compliance matters, quality systems, internal auditing, applicable scientific, business, or technical functions and/or healthcare industry experience.  
•Minimum of 2 years of people management experience required.
•Professional certifications and regulatory, quality systems, or internal audit training certificates in relevant disciplines are preferred
•Strong oral and written communication skills.
•Demonstrated experience in effectively leading cross-functional teams. Self-starter with demonstrated organizational, project management, time management and problem-solving skills.  
•Can comfortably and effectively confront difficult situations and issues in a timely and appropriate manner. 
•Demonstrated ability to balance multiple high priority responsibilities on-time and effectively. 
•Strong interpersonal skills – ability to work closely with people at all levels within the STERIS organization and facilitate the implementation of corrective action; able to work effectively and professionally with external people including Customers and government officials.
•Excellent PC skills, including Microsoft Office applications.  

 

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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 plc is a $3B, publicly traded (NYSE: STE) organization with more than 12,000 employees worldwide.

STERIS strives to be an Equal Opportunity Employer.  


Nearest Major Market: St Louis

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