General Summary
Experienced professional who integrates regulatory knowledge throughout the product lifecycle with aspects of effective management and strategy. This position supports the RA function by leading the coordination and preparation of global regulatory premarket submissions with an emphasis on US, EU, and Canada.
Essential Job Functions
· Support business growth by developing go-to-market strategies for NPI and LCE projects; execute applicable registrations and action plans on time per project deadlines.
Represent regulatory on multidisciplinary teams and communicate regulatory requirements effectively to cross-functional peers (e.g., clinical, global business unit, project management, quality).
Track submission review progress with related authorities (e.g., FDA) and work closely with relevant departments (internal and external) to drive reduction of submission review and approval cycle time.
Conduct appropriate research to develop strong, risk-based regulatory strategies for new products.
Identify potential regulatory risks and advise business of upcoming changes in product regulations; assist in countermeasure development and implementation to ensure quick adaption to the new regulations.
Maintain knowledge and understanding of global regulatory requirements with an emphasis on US, EU, and Canada, and provide expertise in translating regulatory requirements into practical and workable plans.
Evaluate regulatory impact of proposed design and manufacturing changes.
Review and approve all labeling (product, advertising and promotional).
Development of departmental SOPs and implementation.
Maintain regulatory files as required by departmental procedure.
Adhere to Code of Ethics for Regulatory professionals.
All other duties as requested by his/her manager
Knowledge Requirements
Bachelor’s degree, preferably in a scientific discipline such as Science, Pharmacy or Engineering.
Masters in Regulatory Affairs or Regulatory Affairs Certification (RAC) is a plus.
5 to 8 years of Class II medical device regulatory experience is required, aesthetic devices is a plus.
Strong regulatory writing skills.
Ability to apply business and Regulatory Affairs ethical standards.
Excellent analytical and critical thinking skills.
This job description is not all inclusive and is intended to capture a majority of the job functions. Special projects and other tasks may be required by management.