Regulatory Affairs Devices Consultant

We are searching for seasoned regulatory affairs consultants to integrate with clients requiring support e.g., to advise and execute regulatory strategies. Summary of Job RegDev, Inc., is a consulting service organization with global clients investigating drugs, biologics, devices or combination products in multiple therapeutic areas. We are searching for seasoned regulatory affairs consultants to integrate with clients requiring support e.g., to advise and execute regulatory strategies. Essential Duties and Responsibilities Consulting Assignment may include: Lead development of regulatory documents or strategies for US and OUS, e.g., health authority interactions, 510ks/PMAs/IDEs, combination products Interpret regulatory requirements, policies, guidance, and feedback from global health authorities and advise clients on strategic responses and implementation as well as draft responses Execute on regulatory strategies Review regulatory documents and clinical documents for regulatory submissions Act as regulatory lead or participate on client cross-functional core and working teams Provide strategic regulatory advice and feedback to clients regarding projects and development programs Work closely with subject matter experts to draft regulatory documents Conduct risk assessments, analyze risks, advise on mitigation strategies for clients Proactively remain up to date on regulatory landscape Work with minimal supervisory oversight, but know when to ask questions internally in order to ensure solid aligned advice to clients to enable their success

Job Requirements Education:

Bachelor's degree in related field

Experience:

At least 7-10 years experience in Regulatory Affairs Regulatory lead on clinical programs Experience preparing, managing, writing, and filing NDA/BLA/IND/IMPD/510k/PMA/IDE Global experience preferred

Other Skills and Abilities:

Strong, diplomatic, and kind communicator Excellent verbal and written skills Strong working knowledge of US and OUS requirements Critical thinker, willing to say "I don't know the answer, but will follow up" and then do so every time Ability to function at a leadership level, including leading discussions, in client facing team settings ADA Notations Ability to sit for long periods of time, handling, feeling with hands, reaching with arms. Regular communication (hearing/speaking). Some travel may be required; overnight travel may be required as needed. Lifting up to 25 lbs. Routine home and potential onsite office duties including computer keyboard use. Vision requirements include close vision and ability to focus. Noise conditions range from quiet to moderate - home office conditions variable.

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