Senior Regulatory Affairs Specialist

Position Summary

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.

Location

• This is a hybrid position based in our St Louis facility.
• Domestic travel required 5% of time

What you'll do as a Senior Regulatory Affairs Specialist

• 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.

The Experience, Skills and Abilities Needed

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.

Skills

• 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.

What STERIS Offers

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future.

Here is a brief overview of 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

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