Regulatory Affairs Associate

4 days ago

Richmond, Canada bioLytical Full time

**bioLytical** is hiring a diligent Regulatory Affairs (RA) Associate. You are responsible for executing regulatory tasks related to maintenance of current product licenses, obtaining approvals for new or modified products and conducting regulatory assessments for any QMS related activities meeting 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**
- Execute regulatory activities related to product registrations in Rest-of-the-World markets by liaising with Regulatory bodies and business partners as needed.
- Conduct Regulatory assessment for all customer complaints for regulatory reporting of adverse events and report any MDRs as required.
- Review product labelling and marketing material thoroughly for any changes 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.
- Schedule meetings with external parties and taking minute meetings for submission to regulatory bodies.
- 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 or master’s degree in Medical device industry or related field.
- Minimum 2 years of experience in Regulatory or Quality Assurance in the medical device/ related industry
- Knowledge of medical device regulations in Canada, US, EU and ROW (WHO) and good understanding of ISO 13485 and ISO 14971 an asset.
- Strong communication skills and adept report writing skills required
- Medical Device Regulatory certifications and being familiar with IVDR 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
- 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:
$50,000-$55,000

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 #ISO14971 #regulatorybodies #regulation

  • Lead Associate, Regulatory Affairs

    3 days ago

    Richmond, Canada bioLytical Full time

    **bioLytical**is hiring 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...

  • Regulatory Affairs Associate

    1 week ago

    Richmond, Canada bioLytical Full time

    **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...

  • Regulatory Affairs Associate

    4 weeks ago

    Richmond, Canada Rise People 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...

  • Associate, Regulatory Affairs

    3 weeks ago

    Richmond, Canada bioLytical Laboratories Inc. Full time

    bioLytical is hiring a diligent Regulatory Affairs (RA) Associate. You are responsible for executing regulatory tasks related to maintenance of current product licenses, obtaining approvals for new or modified products, and conducting regulatory assessments for any QMS related activities meeting bioLytical’s corporate objectives. You will play a vital...

  • Regulatory Affair Specialist

    1 week ago

    Richmond, Canada Herbaland Naturals Full time

    Job Tittle: Regulatory Affair Specialist Location: 13330 Maycrest Way, Richmond, B.C, V6V 2J7 Herbaland is a leading manufacturer of Plant-based nutrition for a better planet. We are excited to announce we are seeking an experienced Regulatory Affair Specialist to join our team. Herbaland’s culture is inclusive, sustainable, and community based, where we...

  • Regulatory and Customer Affairs Coordinator

    3 days ago

    Richmond, Canada Flair Airlines Ltd. Full time

    **Want to be part of a team that's changing the way Canada travels?** As Canada’s largest independent ultra-low-cost airline, that’s exactly what we’re doing at Flair Airlines. By consistently offering airfares that are a fraction of the ticket prices of “those other airlines”, we are making air travel an affordable option for millions of...

  • Only 24h Left: Regulatory Affairs Associate

    2 weeks ago

    Richmond, British Columbia, Canada Rise People 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...

  • Regulatory Consumer Affairs Manager

    2 days ago

    Richmond, British Columbia, Canada Natures Path Foods Full time

    Key responsibilities: Serve as the subject matter expert (SME) regarding regulatory compliance, labeling and nutritional statement matters. Set the labeling standards and guidelines for all products in all country of sale. Act as an advocate for customer regulatory issues regarding label compliance. Identify, manage, and implement process improvements...

  • Regulatory Operations Intern

    1 week ago

    Richmond Hill, Canada STERIS Full time

    At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. **Position Summary**: The Corporate Regulatory Department is looking for energetic, dynamic and team-oriented individuals to complement our group’s mission to diligently execute critical...

  • Regulatory Affairs Manager

    3 weeks ago

    richmond hill, Canada Advanced Clinical Full time

    Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of...

  • Public Affairs Intern

    2 weeks ago

    Richmond, Canada Domtar Full time

    Domtar is a leading producer of pulp, paper, packaging, tissue and wood products. Through our focus on safety and sustainability, as well as our commitment to operational excellence and our network of facilities across Canada and the United States, Domtar delivers high-quality and cost-effective products to customers around the world. Our workforce is...

  • Corporate Affairs and HSE Manager

    2 weeks ago

    Richmond, British Columbia, Canada Graymont Limited Full time

    Graymont is seeking a driven Corporate Affairs and HSE Manager to lead impactful strategies across the Western North American Region, partnering with plant managers and leaders to drive continuous improvement in HSE programs at Graymont.Job DescriptionReporting to the Director, Corporate Affairs, Environment, & Sustainability for North America, the Corporate...

  • Public Affairs Intern

    2 weeks ago

    Richmond, Canada Domtar Full time

    Domtar is a leading producer of pulp, paper, packaging, tissue and wood products. Through our focus on safety and sustainability, as well as our commitment to operational excellence and our network of facilities across Canada and the United States, Domtar delivers high-quality and cost-effective products to customers around the world. Our workforce is...

  • Public Affairs Intern

    2 weeks ago

    Richmond, British Columbia, Canada Domtar Full time

    Domtar is a leading producer of pulp, paper, packaging, tissue and wood products. Through our focus on safety and sustainability, as well as our commitment to operational excellence and our network of facilities across Canada and the United States, Domtar delivers high-quality and cost-effective products to customers around the world. Our workforce is...

  • Corporate Affairs and HSE Manager

    2 weeks ago

    Richmond, Canada Graymont Full time

    Graymont is seeking a driven Corporate Affairs and HSE Manager to lead impactful strategies across the Western North American Region, partnering with plant managers and leaders to drive continuous improvement in HSE programs at Graymont. Job Description Reporting to the Director, Corporate Affairs, Environment, & Sustainability for North America, the...

  • Public Affairs Intern

    2 weeks ago

    Richmond, British Columbia, Canada Domtar Full time

    Domtar is a leading producer of pulp, paper, packaging, tissue and wood products. Through our focus on safety and sustainability, as well as our commitment to operational excellence and our network of facilities across Canada and the United States, Domtar delivers high-quality and cost-effective products to customers around the world. Our workforce is...

  • Public Affairs Intern

    2 weeks ago

    Richmond, Canada Domtar Full time

    Domtar is a leading producer of pulp, paper, packaging, tissue and wood products. Through our focus on safety and sustainability, as well as our commitment to operational excellence and our network of facilities across Canada and the United States, Domtar delivers high-quality and cost-effective products to customers around the world. Our workforce is...

  • ▷ High Salary! Corporate Affairs and HSE Manager

    3 weeks ago

    Richmond, Canada Graymont Limited Full time

    Graymont is seeking a driven Corporate Affairs and HSE Manager to lead impactful strategies across the Western North American Region, partnering with plant managers and leaders to drive continuous improvement in HSE programs at Graymont. Job Description Reporting to the Director, Corporate Affairs, Environment, & Sustainability for North America, the...

  • (Urgent) Public Affairs Intern

    2 weeks ago

    Richmond, Canada Domtar Full time

    Domtar is a leading producer of pulp, paper, packaging, tissue and wood products. Through our focus on safety and sustainability, as well as our commitment to operational excellence and our network of facilities across Canada and the United States, Domtar delivers high-quality and cost-effective products to customers around the world. Our workforce is...

  • Corporate Affairs and HSE Manager

    2 weeks ago

    Richmond, British Columbia, Canada Graymont Full time

    Graymont is seeking a driven Corporate Affairs and HSE Manager to lead impactful strategies across the Western North American Region, partnering with plant managers and leaders to drive continuous improvement in HSE programs at Graymont.Job DescriptionReporting to the Director, Corporate Affairs, Environment, & Sustainability for North America, the Corporate...