Regulatory Affairs Manager - bioLytical Laboratories Inc.

Regulatory Affairs Manager
Location: Richmond, BC, Canada
Department: Regulatory Affairs
Position: Permanent, Full-Time
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ABOUT BIOLYTICAL
bioLytical Laboratories Inc. based in Richmond, BC, Canada is a privately-owned Canadian
Company federally incorporated in 2002 and focused on the research, development and
commercialization of rapid, point-of-care in vitro medical diagnostics developed using its
proprietary INSTI™ technology platform. Today, the company sells and markets its INSTI™ HIV
test and has a world-wide footprint of regulatory approvals including US FDA approval, Health
Canada approval and CE mark. Our product provides a highly accurate HIV test result in as little
as 60 seconds which translates into a compelling value proposition for patients, healthcare
professionals, and public health organizations.
SUMMARY
Reporting to the Chief Technical Officer, the Regulatory Affairs Manager is responsible for
defining and implementing regulatory strategies to obtain global approvals for new/modified
devices and combination products in order to meet bioLytical’s corporate objectives. This role
requires the ability to analyze complex technical and medical information and formulate strong
regulatory arguments that can be defended with regulatory agencies such as the FDA and
international Health Authorities. The Regulatory Affairs Manager must also ensure compliance
with global regulations for design controls, cGMP, facility registration, device listing, licenses,
safety reporting, complaints, clinical trial requirements, post-market surveillance, labeling, and
permissible marketing communication. The Regulatory Affairs Manager is the head of the RA
department and seen as one of bioLytical’s leaders in moving the company to the next level of
performance.
ROLE AND RESPONSIBILITIES
 Work closely with Senior Management, Sales and Marketing, R&D and Clinical Affairs to
develop the regulatory strategy in order to gain market approval for new or modified
devices/combination products consistent with corporate objectives
 Lead the preparation of complex submissions including PMAs, 510(k)s, Notified
Body/Competent Authority application, Health Canada licenses, WHO and submissions
to other international Competent Authorities
 Maintain a good working relationship by interacting proactively and persuasively with
global regulatory agencies in order to gain approvals
 Guide product development teams in developing new products in accordance with
Design Control regulations
 Ensure clinical studies are designed and executed in full compliance to GCP, ICH, and
pertinent global regulations
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Provide oversight of regulatory assessments for all document, product, and process
changes to ensure that change notifications to regulatory bodies are appropriately
submitted
Ensure product labeling and promotional materials are compliant with regulations
Ensure all national registrations, licenses, listing, and other certifications are maintained
as required for regulatory compliance
Possesses in-depth understanding of US and OUS regulation requirements. Actively
review new laws/regulatory requirements to maintain proficiency in worldwide
regulations and communicate pertinent information.
Responsible for global safety reporting and complaint handling in accordance with
regulations
Manage regulatory staff and contract and manage specialized regulatory consultants as
necessary
Accountable for developing and meeting regulatory timelines and budgets
Participate as a bioLytical representative during inspections by regulatory agencies
QUALIFICATIONS
The successful candidate will meet the following criteria:
 BA/BS in the life sciences, or engineering with MS preferred
 10+ years of regulatory experience in the medical device/pharmaceutical/biologics
industry
 Experience developing and successfully defending complex regulatory submissions for
medical devices (PMA, 510(k)) and combination devices
 Experience directly, and successfully, interfacing with the FDA and other regulatory
bodies
 Experience with Health Canada and international device regulatory submissions
required, including EU and other ROW health authorities
 5+ years of managerial experience required including direct supervisory experience and
experience building and meeting budgets and timelines
 Strategic leadership, strong communication and persuasion skills, and the ability to craft
strong regulatory arguments
 Strong project management and problem-solving skills
 Regulatory Affairs Certification preferred
HOW TO APPLY
bioLytical Laboratories Inc offers a challenging, enriching work environment and competitive
compensation commensurate with experience. For additional details about this opportunity
and to apply, please send a cover letter and resume to [email protected].
We are an equal opportunity employer and invite applications from all qualified individuals.