- 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.
- Strong background utilizing MS Office applications (Word, Excel, PowerPoint, Outlook) .
- 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).
Requirements (Physical, Mental, Environmental Demands):
- Ability to walk up and down several flights of stairs throughout the work day in a multi-location facility
- Must be able to wear personal protective equipment (latex or nitrile gloves, safety glasses/face shields, lab coat, etc.).
- Must be able to adhere to applicable bio-safety practices when on the manufacturing floor.
- Ability to work on a PC including repetitive use of a keyboard and mouse for long periods throughout the course of the work day.
- Ability to sit and stand for long periods of time, stoop, reach, bend throughout the course of the work day.
- Must be able to analyze, concentrate and solve complex issues routinely through the course of the work shift and remain focused in a fast paced open environment throughout the course of the work day.
- Must be able to travel by car/air to other MBI locations and/or supplier locations as needed.
We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing.