Regulatory Specialist - Santa Monica, United States - alphapro technology, a.p.r., inc.

alphapro technology, a.p.r., inc.
alphapro technology, a.p.r., inc.
Verified Company
Santa Monica, United States

3 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Overview:

Duties:


  • Develop and implement regulatory strategies for product approvals and compliance
  • Ensure adherence to FDA regulations and guidelines
  • Coordinate and support regulatory submissions for new products or changes to existing products
  • Conduct regulatory research and stay current on industry regulations
  • Collaborate with crossfunctional teams to ensure regulatory requirements are met
  • Assist in the preparation of documentation for regulatory authorities
  • Participate in audits and inspections as needed

Requirements:


  • Bachelor's degree in a related field; advanced degree preferred
  • Proven experience in regulatory affairs within the pharmaceutical or healthcare industry
  • Strong knowledge of FDA regulations and guidelines
  • Ability to manage multiple projects simultaneously
  • Excellent communication and organizational skills
  • Detailoriented with strong analytical skills
  • Certification in Regulatory Affairs is a plus


Join our team as a Regulatory Specialist and contribute to ensuring compliance with regulatory standards while supporting the development of innovative products.


Job Types:
Contract, Temporary


Pay:
$ $54.00 per hour


Experience:


  • FDA regulations: 1 year (preferred)
- commercial/central


IRB:
3 years (preferred)
- authority logging: 2 years (preferred)
- field of clinic research: 4 years (preferred)
Regulatory Specialist: 3 years (preferred)


Work Location:
On the road
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