Position

REGULATORY SPECIALiST

Pharmaceutical & Medical Device

 

Full-time
Petaluma, California

DESCRIPTION

This position reports to the Director of Regulatory Affairs and supports regulatory activities by complying with GMP/QSR, and EPA requirements. The Regulatory Specialist is responsible for maintaining establishment registration, annual licenses, product listing, and CFG in addition to the following duties:

  • Provides leadership in evaluating, reviewing, analyzing and timely reporting of product complaints to agencies based on regulatory requirements (post market surveillance). 
  • Reviews and assesses product/process changes for regulatory impact (Impact Assessment). 
  • Identifies product labeling requirements and provides regulatory support for the development of labels, promotional and advertising materials. 
  • Performs research on regulations, standards and regulatory pathways as needed. 
  • Develops regulatory procedures and supports quality related activities as necessary. 
  • Assists in pre-audit activities for preparedness and provides support for internal/external audits. 
  • Prepares regulatory submission documents and change notifications.

 

EDUCATION REQUIREMENTS:  

  • Master’s degree in Regulatory Affairs with minimum of 1year experience or Bachelor’s degree in a scientific discipline with 3 years of job related experience.

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Additional EXPERIENCE REQUIREMENTS: 

  • Experience in a regulated industry (Pharmaceuticals, or Cosmetics, Medical Devices, Veterinary or Dietary Supplements). 
  • Cosmetic industry experience is highly desired. 
  • Good understanding of 21CFR part 820, part 700, ISO 13485, ISO 22716 and ISO 14971. 
  • Proficiency in Microsoft Office Suites.
  • RAPS-RAC is desirable, but not required.

OTHER QUALIFICATIONS: 

  • Detail oriented with well-developed organizational and analytical skills. 
  • Ability to work in a team environment and positive attitude is a plus. 
  • Experience working in a fast-paced, start-up environment is a plus.

 


WE VALUE INNOVATION, SCIENTIFIC RIGOR, COLLABORATION AND A PASSION FOR CHANGE.