bioLytical Careers
Senior Associate, Regulatory Affairs
Richmond, British Columbia, Canada .
full-time . November 18, 2024
Description
bioLytical is hiring a Senior Regulatory Affairs (RA) Associate. You are responsible for executing regulatory tasks related to obtaining approvals for new or modified products and maintaining existing product registrations to meet bioLytical’s corporate objectives.
You will play a vital role in driving forward our mission to get people tested with the best technology on the market, living the Core Values through and through.
HOW YOU WILL CONTRIBUTE
- Prepare complex submissions including change notifications, amendments and initial applications to US FDA, Health Canada, Notified Body, WHO. These include but not limited PMA supplements, 510(k)s, new PMAs, Health Canada MDLs, Notified Body/Competent Authorities.
- Lead regulatory activities related to Pre-market approvals or product clearance in the USA from the FDA and inspections when necessary.
- Create technical files in accordance with European IVDR 2017/746 and maintain working relationships with Notified Body during reviews and audits.
- Responsible for preparing pre-submissions to various regulators and scheduling Q-sub/Pre-sub meetings with regulatory agencies, and coordinating internal teams.
- Draft regulatory strategies for any new products for approvals in major markets.
- Lead internal Regulatory meetings with R&D and the sales team and ensure the ongoing projects are managed with multiple stakeholders.
- Responsible for assessing customer complaints for regulatory reporting of adverse events and reporting any MDRs or initiating recalls as required.
- Maintain a good working relationship by interacting proactively and persuasively with global regulatory agencies to gain approvals.
- Participate in the Internal Audit program and External certification audits at bioLytical Laboratories as a key contributor.
WHAT YOU WILL BRING
- Bachelor’s degree in life sciences/engineering.
- Minimum 4+ years of Regulatory Affairs experience in the Medical Device/IVD industry.
- RAC Devices certification will be an asset.
- Demonstrated knowledge of US FDA, Canadian regulations, EU IVDR, and Australian regulations for medical devices and IVD.
- Experience preparing medical device license applications and change notifications for license amendments.
- Proficient Communication Skills required to confidently conduct correspondences with regulators.
- Strong proficiency with MS Office suite and Adobe Professional.
WHAT WE OFFER
- A competitive compensation package
- Extended health benefits including dental - 100% employer contribution
- Flexible working hours
- Paid sick days
- Bonus day off with pay on your birthday every year!
- Full-size in-house fitness gym and shower facilities
- Complimentary reserved parking
- Opportunity to work with industry experts who are motivated and passionate about what they do but know how to have some fun
- A chance to show off your dance moves and singing voice at the company parties and jump in to score a victory or lead the way in our outdoor games at the summer barbeques
- The opportunity to join an ‘off the charts’ foodie culture in our large kitchen and try out your favourite recipes or enjoy the culinary delights as they hit the share table
The annual base salary for this job ranges from:
$70,000-$75,000
bioLytical's pay range is based on multiple factors including experience, education, job-related skills, and equity within the team or organization.
About bioLytical
bioLytical Laboratories Inc. is a privately-owned Canadian company focused on the research, development and commercialization of rapid in-vitro medical diagnostics using its proprietary INSTI® technology platform. bioLytical has won several local and industry awards, including BC Exporter of the Year in 2019 and the Globe and Mail’s Fastest Growing Companies list in 2020. We have been named Lifesciences BC’s Growth Stage Med Tech Company of the Year and have been featured on BC’s Fastest Growing Companies six years in a row. bioLytical moved to a significantly larger, state-of-the-art facility in Richmond in 2020 to accommodate the extraordinary growth achieved through our team.
CORE VALUES
INNOVATION in what we do, how we do it and how we think: Contributes new ideas, challenges the status quo, takes the initiative on projects.
NEVER SAY NEVER: Stays engaged until the goal is reached or project is completed. Overcomes barriers. Cares so much about the task at hand that the impossible is made possible.
SENSATIONAL to our clients, to our partners, to each other: Spirited team player, who adapts to new situations quickly and is beyond reliable.
TAKES OWNERSHIP of goals, decisions, actions, and results: Arrives on time and prepared, leads by example, follows through on commitments.
INSPIRED to excel: Demonstrates a passion for INSTI, our people and our projects. Is not complacent, shares knowledge freely, exhibits awareness of self, their surroundings, and the business.
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