Meridian Bioscience Inc.

Senior Regulatory Affairs Specialist

Meridian Bioscience Inc.

full-time

Posted on:

Origin:  • 🇺🇸 United States • Ohio

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Job Level

Senior

About the role

  • Provides support and guidance to quality and regulatory activities, including Design Control activities, project teams, design transfer activities, clinical trials, validation and verification activities, and existing product modifications.
  • Supports and helps draft sections of regulatory submissions for domestic, world-wide commercialization and other business objectives.
  • Drafts, evaluates, and reviews technical protocols and data in support of clinical trials, validation, verification and product manufacturing.
  • Provides direct support associated with adverse events, medical device reportable events and product recall activities, including corrections and removals.
  • Evaluates the regulatory impact of changes associated with product design change and routine change control.
  • Drafts and reviews, and helps provide guidance for product labeling activities, including Instructions for Use (IFU/PI), to ensure adherence to applicable regulations and standards.
  • Provides regulatory input and oversight to product lifecycle planning, including risk management activities, and monitors product lifecycle and compiles information associated with changes as directed.
  • Compiles new product technical information and feature summaries in support of market expansion.
  • Responds to Sales & Marketing requests to ensure content of collateral and promotional materials is compliant with applicable regulations.
  • Participates in long-term projects supporting the business and quality objectives of the organization.
  • Assists in the management of third party and internal Quality Audit programs; perform supplier audit and verification activities as directed.
  • Other duties as assigned.

Requirements

  • Bachelor of Science degree in Biology, Biochemistry, Microbiology or related field required.
  • A minimum of 4 years of direct Regulatory Affairs experience is required, including preparation of Pre-IDEs, 510(k) applications, EU Technical Files, Canadian Class II and III licenses, STED documentation, etc.
  • Prior experience in FDA/ISO regulated industry; Quality Assurance, Quality Systems, Design Control, Regulatory Affairs or equivalent.
  • Competencies Required or preferred Proven knowledge of FDA and ISO regulated environment (Medical Devices, Pharmaceuticals, In Vitro Diagnostic Medical Devices), including risk management principles (e.g. ISO 14971).
  • Experience with design, development, and clearance of medical devices.
  • Demonstrated strong leadership, project management and organizational skills.
  • Highly motivated, detail oriented, must have a constant awareness of customer requirements and must demonstrate an ability to make fact- driven decisions; maintain accurate and concise records, uphold regulatory and quality system requirements including 21 CFR 820, ISO13485, 98/79 EC, and SOR/98-282
  • Must be organized with strong attention to detail and able to prioritize and balance workloads and meet strict critical deadlines along with performing under pressure in a fast-paced environment.
  • Readily adapts to changing priorities, effectively manages own time, sets priorities to ensure tasks, multiple projects are prioritized and completed on time.
  • Must possess exceptional communication (written and verbal) skills, interpersonal skills, problem solving and ability to interact effectively with all levels of the organization both internally and externally.
  • Ability to speak in large groups and actively engage participants.
  • Strong background utilizing MS Office applications (Word, Excel, PowerPoint, Outlook).