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Form of workAt 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.
Position Summary
The mission of the Regulatory Affairs group is to implement effective processes to obtain and maintain product registration approvals to market STERIS products in designated countries in support of STERIS’s global business plans. This includes determining registration and submission requirements in the various markets and identifying the documentation needed to meet the identified registration requirements. Works closely with Business Unit partners, STERIS Corporate RA domestic staff, STERIS distributors, regulatory consultant contractors and various U.S. and foreign government agencies to prepare and submit required documents. Utilizes electronic record-keeping tools according to departmental policy.
The Senior Regulatory Affairs Manager is expected to have in-depth knowledge of the specific guidance, standards and regulations applicable to the product lines which they are supporting with product registrations to include US EPA, EU BPR and other international markets.
- Home Based / Remote opportunity
- 20% Domestic Travel Required
- 10% International Travel Required
Duties
- 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.
Duties - cont'd
- 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.
Supervision
This position will have direct reports.
Education Degree
- Bachelor's Degree
Required Experience
- 8 years of Regulatory Affairs experience
- 5 years of US EPA Antimicrobial registration experience
- Leadership experience managing a team of people
Preferred Experience
- 5 years of EU Biocides Regulatory experience, PT2 a plus
- 3 years US State Registration experience / International market Disinfectant registration experience (ie. Brazil ANVISA, S.Korea KBPR)
What STERIS Offers
The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid-time off, holidays, matching 401(k), annual merit, and incentive plans. Join us and help write our next chapter.
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Pay range for this opportunity is $130,000 - $148,050. This position is eligible for annual company bonus plan.
Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.
Employees (and their families) may enroll in our company-sponsored medical, dental, vision, flexible spending, health savings account, voluntary benefits, supplemental life/AD&D plans and the company’s 401k plan. Employees are covered by an employee assistance program (also available to household members) and long-term disability. Full-Time Employees are also eligible for short-term disability. Full-time Employees will also receive Paid Time Off (PTO) based on years of service and paid Holidays. Part-time employees working 20 or more hours receive a pro-ration of the full-time PTO allocation and paid Holidays based on their standard hourly work week. Full-Time employees are eligible for four weeks of paid parental leave. Part-time employees also receive paid parental leave, pro-rated based on their standard hourly work week.
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.
