Manager, Regulatory Operations

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 labeling 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, drug/device master files, translation services and other processes as identified.

This is a hybrid role with the requirement of working onsite at our Mentor, OH Corporate HQ, 3 days per week.

As a Manager Regulatory Operations you must have working knowledge of the following regulations and standards:

• Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA)
• 21 CFR Part 801 – Medical Device Labeling
• 21 CFR Part 803 – Medical Device Reporting
• 21 CFR Part 806 – Medical Device Corrections and Removals
• 21 CFR Part 807 – Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
• 21 CFR Part 820 – Medical Device Quality System Regulations (QSR)
• 21 CFR Part 7 – Enforcement Policy, Subpart C – Recalls
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (cGMP)
• 21 CFR Part 11 – Electronic Records, Electronic Signatures
• ISO 13485 Medical devices – Quality management systems
• ISO 9001 Quality management systems – Requirements
• EN ISO 11135-1 Sterilization of healthcare products – Ethylene Oxide
• EN ISO 11137-1 Sterilization of healthcare products – Radiation
• ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
• ISO 14971 Application of Risk Management to Medical Devices
• EU Medical Device Directive and EU Medical Device Regulation
• EU MEDDEV 2 12-1: Guidelines on a Medical Device Vigilance System
• Global Unique Device Identification Database (GUDID) Guidance for Industry
• International Medical Device Regulators Forum (IMDRF) Final Document: Unique Device Identification (UDI) of Medical Devices, December 9, 2013

In this role you will work closely with STERIS corporate domestic and international staff and Customers and U.S. and foreign government agencies. As a Regulatory Operations Manager you will focus on FDA registration and listing requirements for medical devices of STERIS manufacturing sites, labeling review, global Unique Device Identification (UDI) submissions, integration projects and ensure business continuity.

What You'll do as a Manager, Regulatory Operations

• Responsible for the effective management including the training, utilization and supervision of Regulatory Operations staff reporting to the Manager.
• Work with others in Regulatory, Quality & Regulatory Compliance, and affected business partners to update established Corporate Procedures to accommodate the changes in regulations; recommends opportunities to strengthen the internal control structure.
• Responsible for effectively communicating with team members the results of data gathered and creating best practices.
• Set goals, guide project activities, track progress, report status as appropriate, and take action on unexpected setbacks to avoid delays, late filings, or disruption in product availability.
• Report regularly to management concerning project status, identifying and taking action on any unexpected changes, delays, or risk areas.
• Support and participate in the implementation of a new process for the collection, management, and submission of product information to the STERIS UDI System (SUS) via XML files.
• Create and support the maintenance and enhancement of Corporate Regulatory and Global Work Instructions policies and procedures.
• Work closely with people at all levels within the STERIS organization and facilitate the implementation of corrective action; able to work effectively and professionally with external people including Customers and government officials.
• Assist in the development of regulatory policies and procedures with strong working knowledge of policy development and approval process.
• Assist in the investigation and research of compliance issues and ensures assigned remediation tasks are completed on time.
• Assist in regulatory and compliance projects (e.g., audit support, integration, product relocation) as needed.

The Experience, Skills and Abilities

Required:

• Bachelors degree required, preferably with scientific, engineering, regulatory, internal audit, or general business core concentration.
• Minimum 5 years experience in regulatory, preferably in medical device and or pharmaceutical.
• Excellent PC skills, including Microsoft Office applications.
• Experience working on cross-functional teams.
• Previous experience leading/overseeing or project management.
• Experience assigning/delegating tasks holding employees accountable for timelines.

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.
• Bilingual skills are a plus, but not required.
• Experience with risk management is desirable.
• Professional work 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.

Other:

• Demonstrated ability to balance multiple high priority responsibilities on-time and effectively.
• Self-starter with demonstrated organizational, project management, time management, and problem- solving skills.
• Strong interpersonal skills – ability to work closely with people at all levels within the STERIS organization and facilitate the implementation of corrective action; able to work effectively and professionally with external people including Customers and government officials.
• Strong oral and written communication skills.

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

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Pay range for this opportunity is $95,000.00 - $115,000.00. This position is eligible for bonus participation.

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.

STERIS offers a comprehensive and competitive benefits portfolio.

Open until position is filled.

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 and life sciences products and services around the globe. For more information, visit www.steris.com.

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 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.