27 Jul VERANEX, Sr Associate Regulatory Affairs
Veranex is growing to meet the ever-evolving needs of the MedTech industry. If you’re looking to accelerate your career and make an impact in MedTech, please apply below.
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 Senior Regulatory Affairs Associate to assist our 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 Senior Regulatory Affairs Associate will report to our Vice President of Regulatory Affairs 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 THE POSITION
- Oversees, prepares and generates content for 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.
- Routinely interfaces with regulatory authorities to manage submission processes through device commercialization.
- 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.
- Ability to research FDA and Notified Body regulations and standards for regulatory and clinical strategies.
- Support external ISO and FDA audits and inspections as the regulatory representative.
- Participate in design reviews
KNOWLEDGE AND SKILL REQUIREMENTS
- A bachelor’s degree is required, master’s preferred.
- A minimum of 6 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.