·Leads a team of regulatory professionals, interacts with personnel in scientific, technical and/or marketing areas, and collaborates with peers and management to effectively accomplish company goals and objectives.
·Ensures company compliance with the regulatory requirements related to 21 CFR Parts 820 and 1271, European medical device and tissue directives and U.S and international pre-market submission/registration requirements for all classes of devices/tissues.
·Maintains and applies current knowledge of applicable medical device and tissue regulations and standards, provides information and guidance to management and personnel in other areas as needed.
·Develops and communicates strategy on the most timely and cost effective path to market clearance for regulatory submissions.
·Prepares, reviews, provides guidance and/or approves regulatory submissions to US and international regulatory agencies, ensuring accuracy, completeness, consistency, clarity and effective communication.
·Represents the company at industry meetings and conferences, including participation on committees and task forces.
·Manages relationships with FDA and domestic/international “customers” (e.g., regulatory agencies, distributors, healthcare facilities).
EDUCATION/EXPERIENCE REQUIRED AND/OR PREFERRED: (list required and preferred separately)
·Bachelor’s Degree required, preferably in a science or technical discipline.
·Minimum 7 years direct experience in Regulatory Affairs within a medical device or biologics company, including PMA experience, required.Previous experience in clinical laboratory preferred.
·Minimum of 5 years supervisory or management experience required.
·Knowledge of FDA 21 CFR Part 820 and ISO 13485 required.Familiarity with 21 CFR Part 1271 and AATB standards preferred.
·Experience with databases and Microsoft Office Suite including Excel required
KNOWLEDGE, SKILLS AND ABILITIES: (list required and preferred separately)
·Strong interpersonal, organizational, problem-solving and verbal/written communication skills, especially technical writing, required.
·Ability to think/plan strategically while handling details with accuracy required.
·Willingness to travel approximately 20% of the time required.
This position may require the use of personal protective equipment during various tasks/activities including but not limited to, gloves, masks and safety glasses.
List activity requirements and percentage of time:KEY: Not at all (0%), Occasional (1-33%),Frequent (34-66%), Constant (67-100%)
Climbing: Not at all (0%)Bending: Occasional (1-33%)Kneeling/Crawling with force: Not at all (0%)