Regulatory Affairs Consultant (closed)
Principal Duties and Responsibilities (essential functions)
Works closely and assures adequate regulatory support to R&D and asset reconfiguration teams.
Prepares and manages regulatory submissions (US/EU). Submissions include 510k, PMA supplements and IDE’s. 510k, PMA supplement experience is a mandatory for this position.
Conducts critical reviews of key technical documents (aiming to ensure completeness, scientific accuracy, regulatory compliance, consistency with other key documents, and ease of review).
Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills;
Develops and implements creative regulatory strategies, approval schedules, and submission standards to achieve departmental and organizational objectives;
Education and/or Experience
Minimum of 4 years experience in a regulated healthcare industry. Medical Device experience is HIGHLY PREFERRED
Bachelor’s degree required; advanced degree / RAC desirable;
Significant experience with US FDA submissions is mandatory. Examples include but are not limited to: Pre-Market Notifications, original PMA Submissions/ Supplements, and Special Pre-Market Notifications.
Other Skills and Abilities
Excellent verbal and written communication skills
Ability to influence, and negotiate with business partners and regulatory agencies
Knowledge of device regulations and guidance documents
Demonstrated leadership ability
Direct experience with global regulatory submissions