STERIS · 11 hours ago
Senior Regulatory Affairs Specialist
St Louis, MO, US, 63133
Full-time
Hybrid
Mid, Senior Level
$74K/yr - $90K/yr
5+ years expSTERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. The Senior Regulatory Affairs Specialist is responsible for supporting the development and administration of STERIS’s global regulatory responsibilities, including the preparation of submissions for the approval and maintenance of STERIS antimicrobial products.
BiotechnologyHealth CareMedical Device
Responsibilities
Identify regulatory requirements for new products or product enhancements early in the product development cycle
Assure that product registration and maintenance fees are tracked and paid
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
Review and approve labeling and marketing literature
Support Manager, Regulatory Affairs and other Regulatory Affairs staff with all regulatory matters
Provide Regulatory support for product assessments, Safety Data Sheet generation, and Customer inquiries to the Healthcare team
Work with direct Supervisor and senior internal stakeholders to identify key initiatives, which may be affect by present or emerging policies. As part of this, develop and recommend government affairs policy positions to upper management
Other duties as assigned
Qualification
Required
Bachelor's Degree
At least 5 years professional experience including regulatory affairs, quality systems, internal auditing, applicable scientific or technical functions
Preferred
Degree in science, biology, chemistry, environmental engineering or regulatory concentration
Healthcare or Medical Device experience desired
EPA antimicrobial or agricultural pesticide experience is preferred
Experience with 510(k) regulatory submissions is desired
Experience with Healthcare Regulatory product assessments, Safety Data Sheet generation, and Customer inquiries
Professional certifications and regulatory, quality systems, or internal audit training certificates in relevant disciplines is desirable
Bilingual skills are a plus
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