Regulatory Affairs Associate
City: Richmond, BC, Canada
Department: Regulatory Affairs
Position: Permanent, Full Time
Did you know that you no longer have to book an appointment with your doctor and wait weeks to get lab results back for STIs like HIV and Syphilis?
bioLytical’s INSTI is the world’s fastest testing platform – providing results in just 1 minute. Yes, you read that correctly – results in 1 minute not 1 to 2 weeks! We’ve been in business since 2002 and have recently been growing like crazy with the launch of new products all over the world. bioLytical Laboratories has ranked on Business in Vancouver’s Top 100 Fastest Growing Companies list two years in a row and is the winner of the 2018 Lifesciences BC’s Growth Stage MedTech Company of the Year.
The full suite of INSTI tests are greater than 99% accurate and have a world-wide footprint of regulatory approvals including US FDA, Health Canada, World Health Organization Prequalification and CE mark for Europe. bioLytical markets its HIV point-of-care tests, HIV self-tests and dual HIV/Syphilis Multiplex point-of-care tests globally with a strong product pipeline from our research team. INSTI is the world’s fastest test, which means more people tested, more people diagnosed and more people linked to care.
We are looking for agile and energetic people to join us on our mission to end AIDS. With millions of tests already sold, INSTI is trusted by healthcare professionals and recently available to consumers. Come join us on our journey and help make a difference in the world!
Reporting directly to the Manager of Regulatory Affairs, the RA Associate is responsible for implementing regulatory strategies to obtain global approvals for new and modified devices in order to meet bioLytical’s corporate objectives. This role requires the ability to analyze complex technical information and understand and interpret governing regulations and standards. Working closely with the Regulatory Manager, the RA Associate must also ensure compliance with global regulations for design controls, facility and device licenses, safety reporting, complaints handling, clinical trial requirements, post-market surveillance, labeling, and permissible marketing communication.
You live the INSTI Core Values through and through and play a vital role in driving forward our mission to get people tested with the best technology on the market.
INSTI’S 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.
HOW YOU WILL CONTRIBUTE:
- Under the guidance of the Regulatory Manager,
- Prepare complex submissions including change notifications, amendments and initial applications to US FDA, Health Canada, Notified Body, WHO. These include PMA supplements, 510(k)s, new PMAs, Health Canada MDLs, Notified Body/Competent Authority applications, WHO and dossier submissions to other international Competent Authorities
- Provide oversight of regulatory assessments for all document, product, and process changes and submit change notifications to regulatory bodies as appropriate
- Prepare annual reports and renewal submissions to various regulatory jurisdictions
- Involve in the assessment of customer complaints for regulatory reporting of adverse events
- Provide inputs in designing labelling artwork, Instructions for Use and marketing materials compliant with regulations
- Work on document authentication/legalization for submission to Rest-of-the-World Regulatory Authorities
- Develop regulatory strategies for launching new products/new markets
- Familiarize and understand the regulatory requirements from Health Canada, EU, US, WHO and ROW authorities.
- Actively review new laws/regulatory updates globally and communicate pertinent information
- Maintain a good working relationship by interacting proactively and persuasively with global regulatory agencies in order to gain approvals
- Assist product development teams in developing new products in accordance with Design Control regulations
- Participate in the Internal Audit program at bioLytical Laboratories in compliance with all standards and regulations
- Cross-train on certain QA related tasks to support the team as required
- Work closely with the RA Manager, QA team, Sales and Marketing, R&D, Product Support to develop the regulatory strategies and ensure compliance
WHAT YOU BRING:
The successful candidate will meet the following criteria:
- Bachelor or Master’s degree in life sciences
- 1-2 years of experience in Regulatory or Quality in the medical device/ pharmaceutical/ biologics industry
- Strategic leadership, strong communication and persuasion skills, and the ability to craft strong regulatory arguments
- Strong project management and problem-solving skills
- Attention to detail and ability to analyze complex information
- Experience liaising with Regulatory Authorities i.e. US FDA, Health Canada, Notified Bodies will be an asset
- Knowledge of Canadian, US and European regulations, ISO 13485 and ISO 14971 will be an asset.
WHAT WE OFFER:
- A competitive compensation package
- Extended health benefits including dental, optometry, RMT, etc.
- Flexible working hours
- Paid vacation
- Bonus day off with pay on your birthday every year!
- Paid sick days
- Complimentary reserved parking
- Complimentary shuttle to/from the office and River Rock Hotel
- Opportunity to work with industry experts who are motivated and passionate about what they do but know how to have some fun
- Oh and you will also have a chance to show off your dance moves and singing voice at the Christmas parties, lead in lawn bowling or volleyball at the summer barbeques and devour cake at the monthly birthday celebrations
HOW TO APPLY:
Send your cover letter and resume to firstname.lastname@example.org or send us an email if you need additional details about this opportunity. We are an equal opportunity employer and invite applications from all qualified individuals.