Regulatory Affairs Associate

**bioLytical** is looking for an experienced Regulatory Affairs Associate to join our growing Regulatory Affairs Department. This position is 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. If you have proven experience analyzing complex technical information, you understand and can interpret governing regulations and standards and can manage multiple priorities in a fast-paced environment, we want to hear from you

**HOW YOU WILL CONTRIBUTE**:

- Lead regulatory activities related to product registrations in Rest-of-the-World markets including but not limited to the WHO and countries in Asia, Africa and Latin America by creating technical product dossiers in desired formats, facilitating document authentication/legalization, providing routine project updates, liaising with ROW business partners as needed.
- Assess customer complaints for regulatory reporting of adverse events and report any MDRs as required.
- Assess all the changes made that concerns product safety and effectiveness, submit significant changes to regulatory authorities and achieve approvals
- Review and provide input into product labelling and marketing materials to ensure compliance with the governing regulations and company procedures.
- Prepare annual reports and renewal submissions to various regulatory jurisdictions and obtain successful approvals.
- Actively review new external standards/regulations updates globally and communicate pertinent information to responsible teams.
- 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.
- Collaboration with cross functional teams and effective interaction is a key part of the role.

**WHAT YOU BRING**:

- Bachelor or Master’s degree in life sciences.
- Minimum 2-3 years of experience in Regulatory or Quality in the medical device/ pharmaceutical/ biologics industry
- Attention to detail and ability to analyze complex information.
- Excellent written and communication skills in English.
- Working knowledge of the MS Office suite and Adobe professional required.
- Knowledge of medical device regulations in Canada, US, EU (IVDD and IVDR) and WHO PQ.
- Good understanding of ISO 13485 and ISO 14971.
- Experience liaising with Regulatory Authorities i.e. US FDA, Health Canada, Notified Bodies in a professional manner.
- RAC Medical Devices will be an asset.

**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
- Complimentary reserved parking
- Fitness gym with shower facilities
- 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

**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. We have been featured on BC’s Fastest Growing Companies four years in a row including the Globe and Mail’s Fastest Growing Companies list in 2020. We were named BC Exporter of the Year in 2019 and have been named Lifesciences BC’s Growth Stage Med Tech Company of the Year. In 2020, bioLytical moved to a significantly larger, state-of-the-art facility in Richmond 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 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 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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