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Job Title:  Senior Manager Regulatory Affairs & Quality Compliance

Req ID:  32689
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 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. Works closely with Business Unit partners, STERIS Corporate RA domestic staff, STERIS distributors, regulatory consultant contractors and various U.S. and foreign government agencies to prepare and submit required documents. Utilizes electronic record-keeping tools according to departmental policy.

The Senior Regulatory Affairs Manager is expected to have in-depth knowledge of the specific guidance, standards and regulations applicable to the product lines which they are supporting with product registrations.

Duties

The Senior Regulatory Affairs Manager has primary responsibility for the effective management of the functional areas described below, including the training, utilization and supervision of Regulatory Affairs staff reporting to the Manager. 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. The Senior Manager operates independently and is responsible for making critical regulatory decisions in consultation with business unit leaders.

*Identify and keep current with the various international country submission/registration/approval and compliance requirements for marketing STERIS products in their assigned areas or regions where STERIS does business. 

*Effectively interface with government agencies, notified bodies, consultants and authorized dealer representatives as necessary to address registration related issues. Act as person responsible for regulatory compliance as assigned by upper management.

*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. 

Duties - cont'd

*See that all staff members maintain 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.

*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 executive 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.

Education Degree

  • Bachelor's Degree

Required Experience

6 years of Regulatory Affairs experience

Preferred Experience

Skills

 

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:  32689
Job Category:  Regulatory Affairs

Leicester, LCE, GB, LE7 1PF


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