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 accomplished Regulatory Affairs Associate to assist our senior Regulatory staff with U.S. and international strategies, submissions, and reporting/compliance activities. We are looking for a technically strong, self-directed and collaborative individual to work within our organization and in a variety of client settings per project dictates. This Regulatory Affairs Associate will report to a Vice President of Regulatory and must be able to collaborate with our Regulatory, Quality and Clinical staff as well as work independently on appropriate level tasks.
MAJOR DUTIES OF POSITION:
- Generates content for and prepares FDA regulatory submissions for device commercialization (e.g., 510(k)s, PMAs, HUD/HDEs and de novos, as well as FDA responses).
- Performs predicate research for medical devices.
- Performs research and assists in defining regulatory and clinical strategies.
- Summarizes and positions literature review searches from peer-reviewed journals.
- Supports numerous regulatory compliance activities, including processing of complaints and submitting Medical Device Reports and Vigilance Reports.
- Assists in CE Marking activities, including preparation of Clinical Evaluation Reports, Technical Files and Design Dossiers.
- Supports the preparation of pre-submission and IDE packages in preparation for human clinical testing as well regulatory support for IRB submissions.
- Interact with European Authorized Representative.
- Interact with country regulatory authorities as needed.
- Participate and Interact with external ISO and FDA audits.
- Participate in design reviews.
KNOWLEDGE AND SKILL REQUIREMENTS
- A bachelor’s degree is required, master’s preferred.
- A minimum of 2-5 years of related medical device experience expected.
- Knowledge of FDA Regulations and the changing EU Medical Device Regulation (MDR) is required.
- Strong level of professionalism, including verbal and written skills, is necessary; must be prepared to work in a variety of client settings.
- 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.