Senior Regulatory Affairs Specialist

Meridian Bioscience, Inc.•Remote,

About The Position

Responsible for supporting Meridian’s regulatory and quality processes, including Meridian's product realization process, to ensure that Meridian’s activities are consistent with applicable quality and regulatory requirements, especially the design, development and manufacture of medical devices. Assist the regulatory department with product compliance throughout all stages of the product lifecycle, including research, development, transfer, validation/verification, labeling, regulatory submissions, and lifecycle maintenance. Works cross-functionally to ensure that regulatory guidance is provided in support of business objectives.

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
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.

Responsibilities

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.