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Reporting to the Senior Manager, Regulatory Affairs within the RA Department, the incumbent is responsible for supporting the development and administration of STERIS’s global regulatory responsibilities. This includes, but is not limited to, the preparation of State, Federal, and international submissions for the approval and maintenance of the full range of STERIS antimicrobial products. The Incumbent will also provide support for plans to achieve identified corporate regulatory policy objectives, and will be responsible for keeping abreast of, and providing regular reporting, to key business leaders on key regulatory developments that impact STERIS business and Customers. For this position, STERIS products are primarily chemistry-based with US States, US EPA FIFRA, US FDA, US OSHA, Health Canada, EU BPR, EU REACH, ANVISA (Brazil), and COFEPRIS (Mexico) as key regulatory bodies.
Job Responsibility:
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
Requirements:
Bachelor's Degree
At least 5 years professional experience including regulatory affairs, quality systems, internal auditing, applicable scientific or technical functions
Self-starter with demonstrated organizational, project management, time management and problem-solving skills
Experience working effectively on cross-functional teams
Demonstrated ability to balance multiple high priority responsibilities on-time and effectively
Excellent PC skills, including Microsoft Office applications including Excel, Word and PowerPoint
Understanding of chemical / scientific industry
Experience with internal audit process and quality systems
Experience with Healthcare regulatory support for product assessments, Safety Data Sheet generation, and Customer inquiries
Nice to have:
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
What we offer:
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