Responsible for managing tasks/processes and providing expert guidance on activities related to the design, development, and clearance of new products and product modifications.
Will ensure that new products and documentation related to new product design, development, transfer, validation/verification, labeling, and regulatory submissions are compliant with applicable quality and regulatory requirements.
Serves as the department expert and advisor on specialized activities such as Pre-Submissions, 510(k) submissions, PMAs, combination device applications and post-clearance activities and projects.
Provide guidance and participate in drafting of regulatory submissions for domestic, world-wide commercialization and other business objectives.
Authors and reviews technical protocols and data in support of clinical trials, validation, verification and regulatory submissions.
Provides guidance and participates in evaluation of the regulatory impact of changes associated with product design changes and routine modifications to cleared products.
Reviews, and helps provide guidance for product labeling, including Instructions for Use (IFU/PI), to ensure adherence to applicable regulations and standards.
Provides guidance and participates in implementation of new regulations and standards.
Conducts training of new employees, reviews training documentation for co-workers to ensure compliance to regulations.
Other duties as assigned.

Bachelor of Science degree in Biology, Biochemistry, Microbiology, Regulatory Affairs or related field.
At least 7 years of experience in the medical devices industry;
At least 7 years’ experience supporting medical device regulatory submissions (e.g., 510(k)s and/or PMAs);
Proven experience with application of quality and regulatory requirements in the design and development of medical devices.
Professional certification (RAC/ASQ) required.
Demonstrated success in achieving FDA and other regulatory agency approvals and clearances.
Demonstrated knowledge of FDA regulations, In Vitro Device Directive and other national and international regulations and standards.
Ability to work independently and identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner.
Understanding of FDA, EU, MDSAP and ISO standards applicable to the department and consequences of non-conformance.
Computer proficiency required, including Word, Excel and database management.
General knowledge of statistical analysis.

Regulatory Affairs Principal

Key skills