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- 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.
- Assist with assembly, distribution, storage and tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions.
- Respond to requests from foreign government and/or distributors as needed.
- Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products.
- Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products.
- Evaluates risk of proposed regulatory strategies; may offer solutions.
- Reviews proposed labeling for compliance with applicable global regulations.
- Writes and manages the development of package inserts.
- Reviews and evaluations promotion and advertising material for compliance with applicable regulations
- Reviews proposed product changes for impact on regulatory status of the product.
- Communicates with regulatory and governmental agencies with supervision
- Applies FDA regulations to business practices and provides regulatory input, advice and guidance to design teams.
- Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred.
- 1+ years of experience in tissue banking and/or pharmaceutical licensing
- A combination of education and experience may be considered.
- Strong knowledge of FDA regulations and standards governing tissue banking, including 21 CFR Part 1271.
- Ability to identify risk in Regulatory strategies.
- Detail-oriented with strong organizational and project management skills.
- Proficient in Microsoft Word and Excel
- 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.
- A minimum of one year of experience in orthopedic or medical device industry preferred.
- A minimum of 3 years of experience in Regulatory Affairs, Engineering, Quality, or related field preferred.
- 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
Regulatory Specialist - Westminster, United States - GForce Life Sciences
Description
Consultant, Regulatory Specialist, Tissue Bank/Pharmaceutical
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 filings for tissue registrations and ensuring adherence to applicable laws, regulations, and standards.
Duties / Expectations of Role
Mandatory Requirements
Nice to Have
Term & Start