Regulatory Affairs Associate
City: Richmond, BC, Canada
Department: Regulatory Affairs
Position: Permanent, Full Time
bioLytical is hiring!!!
Do you think outside-of-the box while ensuring compliance to regulations?
Does innovation and expansion excite you?
Do you see possibilities in challenges?
If this is you, then read on. We are interested in speaking with you!
bioLytical Laboratories is one of BC’s fastest 100 growing companies and is hiring a Regulatory Affairs Associate (RA Associate). Based in Richmond, BC, Canada, we are a privately-owned Canadian company focused on research, development and commercialization of rapid, point-of-care and home-use/self-test in-vitro diagnostic devices using our proprietary INSTI technology platform.
With a world-wide footprint of regulatory approvals including US FDA, Health Canada and CE mark approvals, we market and sell the INSTI HIV test to 60 countries globally and the INSTI HIV/Syphilis Multiplex test within Europe. With INSTI we provide highly accurate test results in less than 1 minute, much faster than the 15-20 minutes required for tests based on lateral flow technology.
Reporting directly to the Manager of Regulatory Affairs, the RA Associate is responsible for implementing regulatory strategies to obtain global approvals for new and modified devices in order to meet bioLytical’s corporate objectives. This role requires the ability to analyze complex technical information and understand and interpret governing regulations and standards. Working closely with the Regulatory Manager, the RA Associate must also ensure compliance with global regulations for design controls, facility and device licenses, safety reporting, complaints handling, clinical trial requirements, post-market surveillance, labeling, and permissible marketing communication.
HOW YOU WILL CONTRIBUTE:
- Under the guidance of RA Manager,
- Prepare complex submissions including change notifications, amendments and initial applications to US FDA, Health Canada, Notified Body, WHO. These include PMA supplements, 510(k)s, new PMAs, Health Canada MDLs, Notified Body/Competent Authority applications, WHO and dossier submissions to other international Competent Authorities
- Provide oversight of regulatory assessments for all document, product, and process changes and submit change notifications to regulatory bodies as appropriate
- Prepare annual reports and renewal submissions to various regulatory jurisdictions
- Involve in the assessment of customer complaints for regulatory reporting of adverse events
- Provide inputs in designing labelling artwork, Instructions for Use and marketing materials compliant with regulations
- Work on document authentication/legalization for submission to Rest-of-the-World Regulatory Authorities
- Develop regulatory strategies for launching new products/new markets
- Familiarize and understand the regulatory requirements from Health Canada, EU, US, WHO and ROW authorities.
- Actively review new laws/regulatory updates globally and communicate pertinent information
- Maintain a good working relationship by interacting proactively and persuasively with global regulatory agencies in order to gain approvals
- Assist product development teams in developing new products in accordance with Design Control regulations
- Participate in the Internal Audit program at bioLytical Laboratories in compliance with all standards and regulations
- Cross-train on certain QA related tasks to support the team as required
- Work closely with the RA Manager, QA team, Sales and Marketing, R&D, Product Support to develop the regulatory strategies and ensure compliance
WHAT YOU BRING:
- Bachelor or Master’s degree in life sciences
- 1-2 years of experience in Regulatory or Quality in the medical device/ pharmaceutical/ biologics industry
- Strategic leadership, strong communication and persuasion skills, and the ability to craft strong regulatory arguments
- Strong project management and problem-solving skills
- Attention to detail and ability to analyze complex information
- Experience liaising with Regulatory Authorities i.e. US FDA, Health Canada, Notified Bodies will be an asset
- Knowledge of Canadian, US and European regulations, ISO 13485 and ISO 14971 will be an asset.
WHAT WE OFFER:
- A competitive compensation package
- Extended health benefits including dental, optometry, RMT, etc.
- Flexible working hours
- Paid vacation
- Bonus day off with pay on your birthday every year!
- Paid sick days
- Complimentary reserved parking
- Complimentary shuttle to/from the office and River Rock Hotel
- Opportunity to work with industry experts who are motivated and passionate about what they do but know how to have some fun
- Oh and you will also have a chance to show off your dance moves and singing voice at the Christmas parties, lead in lawn bowling or volleyball at the summer barbeques and devour cake at the monthly birthday celebrations
HOW TO APPLY:
Send your cover letter and resume to email@example.com or send us an email if you need additional details about this opportunity.
We are an equal opportunity employer and invite applications from all qualified individuals.