Lead Associate, Regulatory Affairs

bioLytical Laboratories

Richmond

CAD 60,000 - 80,000

Job description

bioLytical is growing! We are on the search for a demonstrated Regulatory Affairs (RA) Associate. You will actively support operations for the market entry of new IVD products and the maintenance of licenses for commercially marketed products. You will share your expertise and help train team members.

As a RAC certified professional with US FDA experience, you 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.

This position is located on-site at our Richmond, BC headquarters.

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.

HOW YOU WILL CONTRIBUTE

Lead the management of regulatory activities involving compliance with government regulations and maintenance of establishment licenses.
Lead regulatory strategy development and analyze design changes requiring regulatory approval before implementation.
Appropriate product classification, preparation of regulatory submissions, and effective negotiation of approvals for device applications from WHO, US FDA, Australia, Health Canada, etc.
Perform regulatory activities, such as analytical studies and clinical evaluation strategy reviews, to meet necessary regulatory requirements.
Responsible for new product application submissions, assessment of post-market changes and surveillance, and labelling reviews.
Provide guidance and interpretation of regulatory requirements to responsible teams such as R&D, Clinical Affairs, Marketing, QA/QC, Senior executives and other associates as needed.
Assist in the management of regulatory compliance activities, including coordination of product recalls and support during audits and inspections.
Provide mentoring and training to team members through the sharing of knowledge, advice and resources.
Acts as SME for regulatory tasks during an internal/external audit and lead Regulatory Affairs’ CAPAs and improvements stemming from internal/external audits.
Lead management review meetings and pre-submission meetings with regulators, submit meeting minutes, and engage necessary cross-functional teams in such meetings.

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.

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.

WHAT YOU WILL BRING

Bachelor’s degree in life sciences/engineering.
5+ years of demonstrated Regulatory Affairs experience in the Medical Device/IVD industry.
RAC Devices certification will be an asset.
Expert professional knowledge of US FDA (510k, De Novo, PMA), 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 Adobe and Microsoft.