Instructor - Pharmaceutical Sciences jobs in Denver, CO

Summary

Our client, an Innovative Medical Device company, has engaged GForce Life Sciences to provide a Regulatory Specialist. This position will report to a Manager within the Regulatory department. This individual will play a crucial role in ensuring compliance with regulatory requirements governing tissue banking operations. They are responsible for submitting state licensing applications for tissue registrations and to ensure adherence to applicable laws, regulations, and standards.

Duties / Expectations of Role

·        Prepare and submit regulatory filings, including applications for tissue establishment registration, product approvals, and amendments, as required by regulatory authorities.

·        Ensure compliance with regulatory requirements, including FDA regulations, Good Tissue Practices (GTP), Good Manufacturing Practices (GMP), and other relevant standards.

·        Maintain and manage documentation related to regulatory compliance, including standard operating procedures (SOPs), protocols, submissions, and reports.

·        Collaborate with quality assurance and quality control teams to develop and implement quality systems that meet regulatory requirements and ensure the safety and efficacy of tissue products.

·        Collaborate with cross-functional teams, including research and development, manufacturing, clinical affairs, and legal, to ensure regulatory considerations are integrated into all aspects of tissue banking operations.

Mandatory Requirements

·        Bachelor's degree in an engineering and/or scientific related field

·        1 years of experience in tissue banking and/or pharmaceutical licensing

·        Strong knowledge of FDA regulations and standards governing tissue banking, including 21 CFR Part 1271.

·        Detail-oriented with strong organizational and project management skills.

·        Proficient in Microsoft Word and Excel

Nice to Have

·        Experience with regulatory submissions, including 510(k) applications, INDs, BLAs, or IDEs, is a plus.

·        Regulatory Affairs Certification (RAC) or Certified Tissue Bank Specialist (CTBS) certification preferred.

·        Experience with MDR and EUDAMED

·        Experience with International and US regulations.

Term & Start

·        3 months with potential to extend

·        ASAP

·        Full time (40 hours/week)

·        Remote OR onsite in Colorado

·        Benefits included (Medical, Dental, Vision, 401k)

·        Interview process – 1, potentially 2 quick interviews