Regulatory Operations Specialist

Position Summary

The mission of the STERIS Regulatory Operations function is to standardize and optimize regulatory activities in support of STERIS’s global business plans. This includes: 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.

As the Regulatory Operations Specialist you must have a working knowledge of the following regulations guidance documents, and standards: 

• 21 CFR Part 820 – Medical Device Quality System Regulations (QSR)
• 21 CFR Part 807 – Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
• 21 CFR Part 11 – Electronic Records, Electronic Signatures
• ISO 13485 Medical devices – Quality management systems
• EU Commission Medical Device Directive 1993/42/EEC (MDD) as amended by 2007/47/EC

These activities require close work with STERIS corporate domestic and international staff. You will have responsibility, when assigned, for performing the duties of the functional areas described below under the guidance and direction of your manager and other Regulatory Operations staff.
 

What You'll do as a Regulatory Operations Specialist

• Responsible for correctly evaluating and updating the FDA’s medical device, drug, food, and tissue listings as required in a timely manner, and as applicable to each registered facility.
• Maintain 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.
• Maintain STERIS Quality Management System policies, procedures and work instructions following STERIS document control processes and communicates and posts approved documents.
• Lead the Document Control Process which includes; ensuring timely and effective communications are sent to all internal stakeholders regarding periodic reviews and all phases of the Doc Control Process ensuring all items are actioned to meet required and assigned dates. Educates and guides stakeholders through the Doc Control Process. 
• Effectively facilitate meetings with internal stakeholders holding authors and stakeholders accountable. Communicates all priority items related to audits and ensures timelines are established. 
• Report regularly to management concerning project status, identifying and taking action on any unexpected changes, delays, or risk areas.
• Conduct daily and weekly tasks of assigned job responsibilities and projects as assigned.
• Assist in the creation and updates of standard work and checklists for use to ensure completion of job responsibilities and project requirements.
• Responsible for maintaining understanding of and compliance with all current active Corporate Procedures applicable to his/her job functions.
• Assist in regulatory and compliance projects as needed.
• Protect company confidential information by properly storing, retrieving and disseminating such information only to those authorized while supporting a safe and secure work environment in alignment with STERIS procedures, and regulatory rules and regulations.
• Maintain conduct in accordance with the principles of the STERIS Code of Business Conduct and comply with all Company policies.
   

The Experience, Skills and Abilities Needed

Required:

• Bachelor's degree required, preferably with scientific, engineering, regulatory, internal audit, or general business core concentration.
• Excellent PC skills, including Microsoft Office applications.
• Experience working on cross-functional teams.
• Previous experience leading/overseeing or project management.

Preferred:

• 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.
• Minimum 2 years' experience, preferably including regulatory affairs, legal or governmental compliance matters, quality systems, internal auditing, applicable scientific, business, or technical functions and/or healthcare industry experience.
• Some experience in the registration of drugs, human cell tissue, medical devices, and/or familiar with contract sterilization processes.
   

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 just 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 & Parental 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 career