Pharmaceutical & Medical Device
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.
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.
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.
- 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.