Regulatory Operations Specialist

3 weeks ago


Mentor, United States STERIS CORPORATION Full time

Job Title: Regulatory Operations Specialist Req ID: 43561 Job Category: Regulatory Affairs Mentor, OH, US, 44060 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. 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. The Regulatory Operations Specialist 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. The Regulatory Operations Specialist will have responsibility, when assigned, for performing the duties of the functional areas described below under the guidance and direction of his/her manager and other Regulatory Operations staff. This is position is based in the Mentor, OH office. Eligible for a hybrid schedule. In office Monday, Wednesday & Thursday and remote Tuesday & Friday. Duties The Regulatory Operations Specialist will focus on supporting STERIS businesses with an emphasis on STERIS Quality Management System, FDA registrations, document control, product registrations (FMR/JPAL), iProcurement, audits, customer support, and regulatory guidance. 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. 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. Maintains STERIS Quality Management System policies, procedures and work instructions following STERIS document control processes and communicates and posts approved documents. Leads 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 facilitates 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. Duties - cont'd Conduct d



  • Mentor, Ohio, United States STERIS CORPORATION Full time

    Job Title:Regulatory Operations SpecialistReq ID:43561Job Category:Regulatory AffairsMentor, OH, US, 44060Description: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 SummaryThe mission of the STERIS Regulatory Operations function is...


  • Mentor, United States At Home Stores LLC Full time

    $15.00/hr The Store Operations Specialist (SOS) leads and trains teams in performing all freight functions, including: unloading, processing, stocking, and resets. Key Roles and Responsibilities * Provides customers a positive shopping experience * Performs cashier duties accurately while processing all transactions per policy. * Maintains 5S standards...


  • Mentor, United States TQ Manufacturing Full time

    Looking for a rock star operations player that loves playing in different spaces and wants to stay buys with real impact work! Summary We are seeking a highly motivated and organized Operations Specialist to join our team and provide key support in a number of areas. In this role, you will play a pivotal role in ensuring the smooth and efficient operations....


  • Mentor, United States STERIS Full time

    Job Title: Customer Data Specialist Req ID: 41451 Job Category: Customer Operations/Customer Support Mentor, OH, US, 44060 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 The Customer Data Specialist is responsible for...


  • Mentor, United States Qualigence Full time

    Director of Manufacturing OperationsLead the facility with compassion and positivity to provide leadership and vision to the Manufacturing Engineering and Quality functions. Create data driven environment where key performance indicators drive a culture of growth and continuous improvement.Build a clear vision for the operations team and establish how this...


  • Mentor, United States Race Winning Brands Full time

    Job DescriptionJob DescriptionDescription:Race WinningBrands (RWB) is the leading manufacturer of racing and high-performance parts sold to automotive and powersports markets. RWB is the preferred source for high-end pistons, engine blocks, cylinder heads, intake manifolds, connecting rods, crankshafts, clutches, transmissions, springs and other engine and...


  • Mentor, United States TQ Manufacturing Full time

    Looking for a rock star operations player that loves playing in different spaces and wants to stay buys with real impact work!SummaryWe are seeking a highly motivated and organized Operations Specialist to join our team and provide key support in a number of areas. In this role, you will play a pivotal role in ensuring the smooth and efficient operations....


  • Mentor, United States TQ Manufacturing Full time

    Looking for a rock star operations player that loves playing in different spaces and wants to stay buys with real impact work!SummaryWe are seeking a highly motivated and organized Operations Specialist to join our team and provide key support in a number of areas. In this role, you will play a pivotal role in ensuring the smooth and efficient operations....


  • Mentor, United States Cleveland Clinic Full time

    At Cleveland Clinic Health System, we believe in a better future for healthcare. And each of us is responsible for honoring our commitment to excellence, pushing the boundaries and transforming the patient experience, every day.We all have the power to help, heal and change lives - beginning with our own. That's the power of the Cleveland Clinic Health...


  • Mentor, United States Best Buy Full time

    As a Samsung Home Theater Expert, you'll work in one of our retail stores to demonstrate and sell home theater products with emphasis on the Samsung brand. First, we'll give you all the training you need to be an expert. Once you're trained, you'll explain complex technology in simple terms to help customers understand and see each product's unique value....


  • Mentor, United States Cleveland Clinic Full time

    Join the Cleveland Clinic team at our Mentor Medical Office Building, where you will work alongside passionate caregivers and provide patient-first healthcare. Cleveland Clinic is recognized as one of the top hospitals in the nation. At Cleveland Clinic, you will work alongside passionate and dedicated caregivers, receive endless support and appreciation,...


  • Mentor, United States Cleveland Clinic Full time

    Our Mentor Hospital is a state-of-the-art facility offering Lake County residents enhanced access to Cleveland Clinic, one of the nation's top healthcare systems. With 4 operating rooms, 34 inpatient care rooms, and a helipad, we are making it easier than ever for our Lake County patients to access high-quality care close to home. Join Cleveland Clinic's...


  • Mentor, United States Mentor Exempted Village Schools Full time

    Position Type: Student Support Services/Intervention SpecialistDate Posted: 5/7/2024Location: CARES/Dr. Jacqueline A. Hoynes SchoolDate Available: 2024-2025 School YearClosing Date: 05/13/2024CARES is a state of the art educational, training and resource facility for children and young adults with autism, their families and the professionals entrusted with...


  • Mentor, United States WellStreet Urgent Care Full time

    University Hospitals Urgent Care by Wellstreet is looking for a talented Practice Manager to oversee our Solon and Mentor clinics located at: 7500 Auburn Rd., Suite 1200, Concord Township, OH 44077 6900 Center St, Mentor, OH 44060 ROLE & RESPONSIBILTIES: Lead urgent care/occupational medicine center's clinical and administrative teams to deliver consistent...


  • Mentor, United States Path Engineering Full time

    Job DescriptionJob DescriptionRoleAs a Swiss Lathe Setup Lead (also known as CNC Lathe Setup Supervisor, Swiss Lathe Operations Lead), you'll be responsible for planning, organizing, scheduling, and assisting with the setup for Swiss Lathes. You'll lead daily activities of the Swiss and/or Mill group, assist with setups and machine operation, and...

  • Quality Engineer

    2 weeks ago


    Mentor, United States The Ascent Group LLC Full time

    Pay Rate $33 - $38.50 MUST HAVE: FAIR and Internal audit experience.POSITION SUMMARY Primary responsibilities are to conduct internal Quality Management System (QMS) audits to AS9100 Rev. D for all for 4 value streams. Secondary responsibilities are to provide internal FAIR support, external audits support and support materials control lab for if...


  • Mentor, United States Merritt Full time

    PURPOSEPerform all tasks necessary to complete daily schedules with full accountability in the most efficient and effective manner within the Veneer Department. Work consists of routine tasks, processes and performing operations prescribed by drawings, work orders and procedures. RESPONSIBILITIES:Directly responsible for the selection and lay-out of any and...

  • Relationship Banker

    5 days ago


    Mentor, United States First National Bank of Pennsylvania Full time

    Primary Office Location:7323 Center Street. Mentor, Ohio. 44060. Join our team. Make a difference - for us and for your future. Position Title: Relationship Banker Business Unit: Retail Reports to: Varies Based on Assignment Position Overview: This position is expected to develop proficiency of basic consumer banking transactions, account servicing, and...

  • Relationship Banker

    3 weeks ago


    Mentor, United States F.N.B. Corporation Full time

    Primary Office Location: 7323 Center Street. Mentor, Ohio. 44060. Join our team. Make a difference - for us and for your future. Position Title: Relationship Banker Business Unit: Retail Reports to: Varies Based on Assignment Position Overview: This position is expected to develop proficiency of basic consumer banking transactions, account servicing, and...

  • Sales Associate

    5 days ago


    Mentor, United States Individually Owned and Operated Ace Hardware Store Full time

    Full and part time 20 to 40 hours. Pay is hourly $9.00. General Summary The Sales Associate will assist in the receiving, stocking, pricing of all merchandise and help maintain a clean and orderly merchandise presentation and overall store cleanliness. Essential Duties & Responsibilities **Customer Service**: Provide a positive representation of Burgers...