The Manager, Regulatory Affairs is responsible for providing guidance to Regulatory staff to support global regulatory submissions and regulatory strategies. Responsible for managing regulatory staff assigned to specific product and/or project areas. Responsible for the development, maintenance, review and enhancement of documentation, training, auditing, and compliance.
Essential Job Functions
Direct management of regulatory affairs personnel, consultants, and projects by setting performance standards, performing annual reviews, and overseeing project management, progress, and timely completion.
Prepare and provide guidance for other employees related to Regulatory Strategy
Review and approve all design control documentation, global submissions, engineering change requests for design, manufacturing, and labeling changes, customs requests, and deviations to ensure compliance with FDA and international government regulations
Represent the company with regards to regulatory strategies, submissions, and discussions/negotiations with regulatory authorities.
Work with in-country personell/consultants to manage global submissions.
Maintain departmental performance metrics
Project and budget management
Ensure that internal training programs, policies and procedures are implemented and continuely evaluated and updated to maintain compliance with current regulatory and industry standards
Proven leadership skills
Ability to prioritize, multi-task and adapt to changes
Ability to work within budget constraints
Ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents.
Ability to write, review, and provide training on detailed technical regulatory submissions, reports, and business correspondence
Ability to effectively present information to other employees, management, and regulatory agencies
Computer skills, including Microsoft Office Suite and Microsoft Outlook
Education and Experience
Bachelors degree in engineering, life sciences or equivalent technical field
5-10 years experience in the regulatory field or regulated industry
Experience with medical devices, orthopedics preferred
Extensive knowledge of FDA and applicable international regulations and standards required
Experience with planning and preparing complex regulatory submissions for global filings to include, but not limited to the US (i.e., PMA, IDE, 510(k)) Europe and Japan.
Wright Medical Group N.V. is a global medical device company focused on Extremities and Biologics. We deliver innovative, value-added solutions improving quality of life for patients worldwide. We are a recognized leader of surgical solutions for the upper extremities (shoulder, elbow, wrist and hand), lower extremities (foot and ankle) and biologics markets, three of the fastest growing segments in orthopaedics.