Regulatory & Compliance Coordinator

Vancouver, BC | Full-time

What do you envision your next career to look like? Join MetaOptima to make a difference in the lives of millions as we revolutionize the dermatology industry with artificial intelligence-powered software solutions for faster, more effective, and affordable care. MetaOptima is full of passionate, innovative people who thrive on working together as a team to build smart, life-saving technologies for medical professionals and their patients. Our casual, open-office culture welcomes fresh ideas from the minds of doers. Join our fast-growing startup to add your voice to our vision while working with a cool group of people set on making their mark on the world.  We take pride in what we’ve accomplished together, and can’t wait to see how you’ll help us grow.

A team who works together, wins together. We’re excited to share some of our accomplishments with you:

  • A BCIC New Ventures Competition Winner

  • Plug and Play Startup Showdown Winner

  • BCIP Innovation Challenge Award Winner

  • Coast Capital Savings Venture Prize Winner

  • A Ready To Rocket Winner 2018 & 2019

  • Winner of ISIC Disease Classification Competition 2018

  • Member of Canada’s Digital Technology Supercluster

  • Winner of ITAC Ingenious of the Year Awards, 2019


Temporary Position - Maternity leave replacement (6-8 months) with a possibility of extension or conversion to full time role.


Requirements:

  • Experience with medical devices - including both hardware and software. 

  • Knowledge in worldwide medical device regulations , privacy regulations and quality management system - preferable. 

  • Preferable academic background in Science, biomedical, electrical or software. 

  • Related certification such as - RAC, Internal Auditor 13485, CRA 


Personal Skills: 

  • Scientific interests, training and/or experience 

  • Legal and regulatory interests 

  • Good writing skills 

  • Negotiation skills 

  • Good communication skills applicable to internal and external audiences 

  • A detailed oriented approach 

  • Organizational skills 

  • An analytical mindset 

  • Project Management abilities


Key Responsibilities:

Medical Device Regulations 

  • Support Quality Management System activities including (but not limited to) : 

    • CAPA, NCRs, customer complaints, Internal audits, QSMR,reviewing and updating SOP. 

Supporting product pre-market activities: 

  • Market research for new standards and updated regulations, conducting gap analysis

  • Preparing, maintaining and reviewing quality and regulatory deliverables such as - Quality Plan, Technical File, Essential Requirements, regulatory strategy, product classification, Declaration of Conformity, Clinical Evaluation, and post market Surveillance.

  • Reviewing Labeling - IFU, Marketing materials

  • Supporting worldwide product registration including - Health Canada, FDA , TGA , MEDSAFE, EU, Brazil. 

Supporting Post Market Activities: 

  • Assessing design changes 

  • Assessing reportability criteria 

  • Collecting customer feedback 

Privacy Regulations: 

  • Supporting and maintaining product privacy and annual privacy related activities including but not limited to privacy training, privacy audits, privacy agreements etc. 


Benefits:

Our office is located in downtown Vancouver and is easily accessible by bus, SeaBus, SkyTrain, and West Coast Express. We offer a competitive salary, vacation, stock options, and a comprehensive benefits package (including extended health, vision, and dental). 

If you are interested and passionate about doing things that really matter send us your resume and join us on this amazing journey.


Please Note: Thank you for your interest in joining our team in the fight against skin cancer! We always do our best to contact all applicants, however due to high volumes we will prioritize those under consideration and may not be able to get back to you.

MetaOptima is proud to be an Equal Opportunity Employer, which means that all employment decisions are based on talent (never race, color, creed, age, sex, gender, sexual orientation, national origin, religion, marital status, medical condition, physical or mental disability, military service, pregnancy, childbirth or any other classification protected by law). Diversity, respect, and fairness are our key values; this extends to all areas of the company’s hiring process, including compensation, benefits, discipline, transfer, termination and all other terms of employment.

Here at MetaOptima, we strive to ensure everyone feels welcome to our team; members with qualified disabilities will be provided with reasonable accommodation upon request to fit their needs to help them succeed.

MetaOptima’s management team will always take responsibility for ensuring that the company continues to offer fair, welcoming, and equal employment opportunities. We invite you to share this initiative by taking personal actions that uphold our core values.


Regulatory & Compliance Coordinator

Vancouver, BC | Full-time