We are a dynamic group of professionals providing regulatory, quality and clinical services for the medical device industry. Our team supports start-ups, mid-sized private companies and the largest corporations at all stages of the product life cycle. We work across a broad spectrum of technologies and treatment modalities; our clients develop both next generation and paradigm shifting devices. Our product exposure includes implantables, instruments (manual, laser, robotic, etc.), capital equipment, combination products, medical mobile apps, in vitro diagnostics and more.
We are seeking an experienced Regulatory Affairs Manager to support U.S. and international regulatory activities as well as be an individual contributor on regulatory projects for Experien Group clients.
MAJOR DUTIES OF POSITION:
- Develops and establishes strategic regulatory plans and interfaces with project team members, both within the organization and with a diverse range of clients, to drive client corporate initiatives to completion.
- Assumes a leadership role for project management. Works independently to represent regulatory affairs on project teams bringing novel products and manufacturing processes from concept, through development, to market for clients. Ensures product registration requirements are understood by project teams in order to create technical reports during development that will support global registrations.
- Reviews and approves product labeling and marketing material, including websites and social media. Initiates new package inserts and other required product labeling.
- Manages/prepares elements of regulatory submissions (e.g., IDEs, 510(k)s, PMAs, HDEs, Technical Files, Design Dossiers, and international registrations).
- Manages preparation of for pre-submission packages, Humanitarian Use Device designation requests and Non-Significant Risk proposals for regulatory and clinical activities.
- Prepares regulatory/clinical strategy packages for executive review, including performing predicate research and relevant literature review from peer reviewed journals.
- Reviews clients’ design history file documentation, including verification/validation, biocompatibility, sterilization, transit and aging documentation, risk management documentation and device draft labeling.
- Prepares Clinical Evaluation Reports for executive review in accordance with current standards.
- Processes and reviews clients’ complaint files (including submission of MDRs, Vigilance Reports and Mandatory Problem Reports).
KNOWLEDGE AND SKILL REQUIREMENTS
- A technical degree is required, master’s preferred.
- A minimum of 5-8 years of related work experience.
- Cardiovascular and Digital Health (SaMD) experience highly desired.
- Knowledge of FDA’s Quality System Regulation (QSR) and the changing EU Medical Device Regulation (MDR) is required.
- High level of professionalism, including strong verbal and written skills, is mandatory.
- Strong leadership attributes are necessary. Candidate will lead cross-functional discussion and drive projects to completion. Mentors junior staff on regulations and company policies and procedures.
- Candidate should possess exceptional project management and technical writing skills.
- Medical, Dental and Vision Benefits
- 18 Days of Paid Time-Off (PTO)
- 11 Paid Holidays
The above description is intended to describe the general content, identify the essential functions of, and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.