Based in Dartmouth, Precision BioLogic Inc. (PBI) is a privately-held medical device company that develops, manufactures and markets a range of specialty diagnostic products used to assess blood coagulation disorders in clinical laboratories around the world. The company has developed a strong reputation in its niche and counts most of the major hospitals and reference laboratories in North America among its direct customers.
We are currently seeking a Regulatory Affairs Specialist to join our Compliance and Product Development team. You will collaborate with QA, R&D, manufacturing, customers and regulatory agencies to provide accurate and timely information regarding our products and systems (i.e. ccoordinate and document all internal regulatory processes, such as internal audits, inspections, license renewals or registrations). This role requires quick and accurate turnaround on assigned projects and a positive attitude.
Reporting to the Vice President of Compliance and Product Development, the Regulatory Affairs Specialist will assist with the regulatory strategy, regulatory submissions, and product risk management for new and existing PBI products. You will assist with ensuring conformance with FDA regulations (including 21 CFR Part 820 and all additional applicable FDA regulations), ISO 13485, ISO 14971, and all aspects of cGXP as they relate to our products.
- Generate regulatory submissions in support of new/current products
- Maintain awareness and understanding of regulatory requirements in all markets where our products are sold
- Investigate regulatory requirements for new market opportunities
- Maintain and improve on our recall and vigilance procedures and support mock recalls
- Participate in risk management activities throughout the product lifecycle
- Backup for lot file review
- Support internal audits
- Develop and improve our post market surveillance system
- Provide regulatory support for Unique Device Identifier (UDI) requirements
- Perform UDI submissions and updates to GUDID and EUDAMED
- Maintain and improve upon our technical files
- Develop tools to aid in the management of our regulatory and quality functions
Professional Knowledge & Skills:
- Detailed knowledge of ISO 13485 and ISO 14971
- Good knowledge of working under quality system
- Effective communication – written and oral
- Technical writing
- Strategic thinking – ability to provide a contribution into regulatory strategy and evaluate potential impact on overall project/product strategy
- Enterprise thinking – need to understand the constraints and drivers of other functions and the potential impact on regulatory affairs, including how it may facilitate achieving the overall corporate goal
- Quality mindset
- BSc in Life Sciences or related field
- 2+ years of significant experience in regulatory affairs, or appropriate relevant experience
- ASQ/RAPS Certification
- Trained Quality Systems Internal Auditor (ISO 13485:2003 and FDA QSR) considered an asset
Compensation will be commensurate with experience. If you’re interested in joining our team, please submit your résumé in confidence, along with compensation expectations.