Please carefully review the position requirements before submitting your resume
The Sr. Regulatory Affairs Specialist is responsible for support of a variety of regulatory activities and projects with oversight from senior regulatory staff. The focus is on representing RA in new product development core team(s), completing high quality US 510(k) and EU technical files (both IVDD and IVDR) per project plan, and obtaining timely 510(k) clearance for U.S., and Notified body approval of tech files for EU.
- Represents RA in new product development team(s). Responsible for completion of RA strategy, review and approval of design control related documents.
- Writes and owns the completion of high quality 510(k)s and/or Technical Files with limited supervision.
- Acquires FDA clearance of 510(k)s, and Notified Body’s approval of technical files, with desired claims, per project plan.
- For changes to products and processes, conducts regulatory assessments, authors and maintains Letters to File, and tech files updates.
- Works will entail problems of moderate complexity and diverse scope, including data analysis and ownership of task execution and completion.
- Assists in implementing department procedures and maintaining regulatory requirements.
- Provides support to Sr. RA manager, and performs other related duties and assignments as required.
- 3 years of U.S. 510(k) and EU technical file experience for IVD instruments, software, and/or reagents required.
- Familiar and or experience with regulatory requirements for IVD manufacturers such as design control requirements, listings, establishment registrations, etc.
- Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. This includes analytical problem solving
- Ability to balance multiple tasks and to prioritize and schedule work to meet business needs.
- Ability to identify areas of concern in moderately sophisticated projects and manage changes.
- Proven organizational and planning skills, including process savvy, driven, focused and working towards results
- Excellent team skills with ability to influence others without authority.
- Excellent interpersonal skills, ability to communicate and work in a team with varied strengths' environment; effective interactions with technical personnel (scientific and legal). This includes excellent written and verbal communication skills
- Ability to write high quality submission documentation
- Digital literacy (SAP, Microsoft Word / Excel / PowerPoint)
- Detail oriented, with emphasis on accuracy and completeness
- Education and Experience:
- B.S. degree in health science or life science field (biomedical engineering, engineering, computer science, biology, medical technology, etc.). Masters preferred. RAC Certification a plus.
- A Minimum of 3 years’ experience working in an U.S. FDA/ or ISO regulated environment.
- EU IVDR experience a plus.
- Flow cytometer experience a plus.
Base Salary - $115,000 to $120,000
Seniority Level - Mid-Senior
Minimum Education - Bachelor's Degree
Willingness to Travel - Never