Job Title:  Senior Regulatory Affairs Specialist

Req ID:  44381
Job Category:  Regulatory Affairs

St. Louis, MO, US, 63133

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.

The Role

Reporting to the 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.

Position is Hybrid/St. Louis, MO based.

What You Will Do

  • 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.
  • 7.Support Manager, Regulatory Affairs and other Regulatory Affairs staff with all regulatory matters.
  • 8.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.

What You Need To Be Successful

Minimum of five (5) years professional experience including regulatory affairs, quality systems, internal auditing, applicable scientific or technical functions and/or healthcare industry experience.

Bachelor's degree + 

  • Regulatory Affairs – gathering information to support regulatory submissions. Use of this information to prepare regulatory submissions in a complete, thorough format to support STERIS product claims – five years
  • Scientific or Technical Functions – Understanding of chemical / scientific industry, in particular the workings of the regulatory and legislative environment in these function – four years
  • Internal Auditing, Quality Systems - Regulatory support as Quality Assurance Unit for R&D testing and other on site audits – one year
  • Healthcare – Regulatory support or product assessments, Safety Data Sheet generation, and Customer inquiries – one year

________________________________________________________________________________________________

  • Ability to work cross-functionally, across business unit segments, R&D and Marketing
  • Organized. Prepare and/or review written materials; work on product teams to develop regulatory strategies. Maintain product records on STERIS platforms.
  • Record keeping, maintaining pending registrations and actions required to complete registration activities in a timely manner.
  • Effective communication, listening and interpersonal skills. Communications with Regulatory bodies
  • Integrity. Act as spokesperson, when appropriate, regarding STERIS’s practices, policy, business interest.

What Will Help You

  • EPA antimicrobial or agricultural pesticide experience is preferred.

What STERIS Offers

At STERIS, we are making a difference for our Customers every day. We don't just create products. We create amazing solutions that help reduce the threat of infection.  We are the best at what we do. Our people make it so. We attract a variety of talented people who are simply...extraordinary. Our teams are doing remarkable things together. Because at STERIS, we know that no matter what role you have, you can make an impact.  And we find that pretty energizing. 

#LI-LD1
#LI-HYBRID

 

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention.  WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.  We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.

Req ID:  44381
Job Category:  Regulatory Affairs

St. Louis, MO, US, 63133


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