Associate Ii, Regulatory Affairs

4 weeks ago

Richmond, Canada bioLytical Full time

**bioLytical** is hiring an experienced 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**
- 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. This includes creating/revising regulatory submissions in desired formats, facilitating document authentication/legalization, providing routine project updates, and liaising with ROW business partners as needed.
- Draft regulatory strategies for any new products for approvals in major markets.
- Assess customer complaints for regulatory reporting of adverse events and report any MDRs as required.
- Review and provide input into marketing/sales 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.
- Schedule Q-sub/Pre-sub meetings with regulatory agencies and coordinate internal teams.
- 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 3+ years of Regulatory Affairs experience in the Medical Device/IVD industry.
- Medical Device Regulatory certifications (RAC -Devices) will be an asset.
- Professional knowledge of US FDA, Canadian regulations, EU IVDR, and Australian regulations for medical devices and IVD.
- Proficient Communication Skills required to confidently conduct correspondences with regulators.
- Attention to detail and ability to analyze complex information.
- 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:
$60,000-$65,000

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.

\#regulatoryaffairs #manufacturing #medicaldevice #ISO13485 #

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