Senior Regulatory Affairs Specialist
1 month ago
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.
Position Summary
The mission of the STERIS Regulatory Affairs function is to standardize and optimize regulatory activities across product lines and divisions in support of STERIS’s global business plans. This includes: obtaining and maintaining Canadian market authorization of STERIS’s medical devices, biocides and chemical products, determining Canadian submission requirements, working with cross-functional partners to manage compliance activities that impact business in the Canadian market, updating senior leaders on key regulatory developments that impact Customers or STERIS’s business directly, identification and management of global labelling and UDI requirements; determining registration and listing requirements in the US and working with STERIS facilities, customers, and suppliers to comply with these requirements; supporting traffic partners and regulators to resolve import/export issues; working with STERIS International Regulatory staff to identify requirements in other targeted markets; working with product acquisition and development teams to ensure regulatory requirements are met; and administering assigned corporate compliance activities such as document control, record retention, translation services and other processes as identified.
*This position is located in Richmond Hill with a hybrid work schedule.
Duties
• The Senior Regulatory Affairs Specialist will focus on supporting STERIS businesses with an emphasis on STERIS corporate and regional Quality Management Systems, Canadian registrations, FDA registrations, document control, regulatory database maintenance, audits, Customer support, and regulatory guidance.
• Assist with the evaluation and update of external regulatory listings and databases in a timely manner.
• Maintains paper and electronic submission documents, shared drive folders, portals, and databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information.
• Assist with management of daily order and quote holds to assess for product release to meet local requirements in a timely manner.
• Identify regulatory requirements for product changes and for new products or product enhancements early in the product development cycle. This includes working on product teams to develop regulatory strategy based on regulatory submission requirements.
• Support Regulatory Affairs post marketing compliance activities as necessary in assigned regions. This includes adverse event and recall notifications to regulatory authorities and participation in compliance activities as requested.
• Gather information to support regulatory submissions. Use this information to prepare regulatory submissions in a complete, thorough format to support STERIS product claims.
• Assist in regulatory and compliance projects as needed.
• Report regularly to management concerning project status, identifying and taking action on any unexpected changes, delays, or risk areas.
• Synthesizes and actively supports STERIS Regulatory Affairs management’s Regulatory Strategy and accurately communicates it to business partners throughout the project. Engages Regulatory management as necessary when changes occur or new risks or requirements are identified, and proposes actions as appropriate.
• Responsible for maintaining understanding of and compliance with all current active Corporate Procedures applicable to this job functions.
Required Experience
• Four (4) year degree required, preferably with scientific, engineering, regulatory, internal audit, or general business core concentration.
• 2+ years Regulatory experience, preferably in medical device and/or pharmaceutical industries.
• 2+ years professional work experience with legal or governmental compliance matters, quality systems, internal auditing, applicable scientific, business, or technical functions and/or healthcare industry experience.
• 2+ years experience working on cross-functional teams.
• Previous experience leading/overseeing projects or project management.
• Excellent PC skills, including Microsoft Office applications.
• Professional certifications and regulatory training certificates in relevant disciplines are desirable, as is completion of or actively working towards an advanced degree in a relevant discipline.
• Experience with risk management is desirable.
• Experience in the registration of drugs, human cell tissue, medical devices, and/or familiar with contract sterilization processes preferred.
• Ability to communicate in French is an asset.
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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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.
STERIS strives to be an Equal Opportunity Employer. STERIS is committed to treating all people in a way that allows them to maintain their dignity and independence. We believe in integration and equal opportunity. Accommodations are available throughout the recruitment process and applicants with a disability may request to be accommodated throughout the recruitment process. We will work with all applicants to accommodate their individual accessibility needs.
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