STERIS · 16 hours ago
Senior Manager, Regulatory Affairs
United States
Full-time
Remote
Senior Level, Lead/Staff
$122K/yr - $158K/yr
8+ years expSTERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. The Senior Manager, Regulatory Affairs is responsible for implementing effective processes to obtain and maintain product registration approvals and ensuring compliance with regulatory requirements across various markets.
BiotechnologyHealth CareMedical Device
Responsibilities
Identify and keep current with the various US EPA, EU BPR and other 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
See that all direct team 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
Review and approve product literature
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
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
Conduct daily activities of assigned job responsibilities and projects as assigned
Qualification
Required
Bachelor's Degree
8 years of Regulatory Affairs experience
US EPA Antimicrobial registration experience
US State Registration experience
Leadership experience managing a team of people
Ability to travel as noted above
Preferred
EU Biocides Regulatory experience
PT2 experience is a plus
International market Disinfectant registration experience (ie. Brazil ANVISA, S.Korea KBPR)
Benefits
Market Competitive Pay
Extensive Paid Time Off and (9) added Holidays
Excellent Healthcare, Dental and Vision Benefits
Long/Short Term Disability Coverage
401(k) with a company match
Maternity and Paternity Leave
Additional add-on benefits/discounts for programs such as Pet Insurance
Tuition Reimbursement and continued education programs
Excellent opportunities for advancement in a stable long-term care
Company
STERIS
STERIS is a leading provider of infection prevention and other procedural products and services, focused primarily on healthcare, pharmaceutical and medical device Customers.
10001+ employees
H1B Sponsorship
STERIS has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (26)
2024 (28)
2023 (15)
2022 (33)
2021 (18)
2020 (19)
Funding
Current Stage
Public CompanyTotal Funding
$0.28M2010-05-21Post Ipo Debt· $0.28M
1998-12-01IPO
Leadership Team
Daniel Carestio
President and CEO, STERIS
Walter Rosebrough
CEO Emeritus & Senior Advisor
Recent News
GlobeNewswire
2026-01-22
2025-11-05
Company data provided by crunchbase