The Regulatory Affairs and Design Assurance professional, Level I (RADA I) will be responsible for supporting Meridian’s Product Realization Process and ensuring products are designed and manufactured in a manner consistent with applicable Regulatory Requirements. The RADA Associate will be responsible for ensuring product compliance throughout all stages of the product lifecycle: Research, Development, Transfer, Validation/Verification, Labeling, Regulatory Application and Lifecycle Maintenance. The RADA Associate will work with cross-functional teams to provide Regulatory guidance in support of business objectives.
Provides Quality and Regulatory support to Design Control activities, including research and development, design transfer, clinical trials, validation and verification for new product introductions and existing product modifications. The RADA professional will serve as the Quality Assurance/Regulatory Affairs Project Team Representative for design projects.
Prepares product regulatory submissions in support of world-wide commercialization and business objectives.
Evaluates technical protocols and data in support of Clinical Trials, Validation, Verification and product manufacturing.
Directs activities associated with adverse events, medical device reportable events and product recall activities.
Evaluates regulatory impact of changes associated with product design change and routine change control.
Drafts and reviews product labeling, including Instructions for Use (IFU/PI), to ensure adherence to applicable regulations and standards.
Supports international distribution of product by ensuring export and regulatory requirements are satisfied prior to purchase order release.
Provides regulatory input to product lifecycle planning.
Monitors product lifecycle and compiles information associated with changes as directed.
Compiles new product technical information and feature summaries in support of international market expansion.
Manages and completes long-term projects supporting the business and quality objectives of the organization.
Other duties as assigned.
BS in Biological Science, Microbiology, Chemistry or equivalent.
Knowledge of FDA and ISO regulated environment (Medical Devices, Pharmaceuticals, In Vitro Diagnostic Medical Devices strongly preferred).
A minimum of three years experience in FDA/ISO regulated industry; Quality Assurance, Quality Systems, Design Control, Regulatory Affairs or equivalent preferred.
A minimum of three years of Regulatory Affairs experience is preferred, including preparation of Pre-IDEs, 510(k) applications, EU Technical Files, Canadian Class II and III licenses, STED documentation, et cetera.
Knowledge of design, development and clearance of Medical Device preferred.
Professional certifications such as CQA, CQE or CQM/OE preferred.
Skills, Specialized Knowledge and Abilities:
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.
Demonstrated working knowledge of US FDA Quality System Regulations and ISO Quality Management System Standard for Medical Devices.
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.
Ability to read, understand and follow all company SOPs and guidelines.
Ability to maintain regular attendance and punctuality requirements. May be required to work additional hours outside of the normal work shift to ensure departmental goals are met (evenings and weekends).
Meridian is a fully integrated life sciences company that manufactures, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies.