Regulatory and Compliance Specialist

MetaOptima • Vancouver, BC

81d

About The Position

Join MetaOptima to make a difference in the lives of millions as we revolutionize the dermatology industry with software, hardware and AI 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 us 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.

We’re looking for a Regulatory and Compliance Specialist with experience in medical device Quality Management Systems. The incumbent must be familiar with medical device-related regulatory requirements in one or more of the following countries: Canada, US, Europe, Australia and the United Kingdom. Familiarity with standards such as ISO 13485: 2016 and ISO 14971: 2019 is expected. Experience with EU MDR and MDSAP auditing processes is an added advantage.

Requirements

• Practical understanding of ISO 13485 and ISO 14971.
• Exposure to IEC 62304, FDA QMSR, EU MDR, CMDR and Australian Therapeutic Goods (Medical Devices) Regulations.
• Knowledge of design controls, risk management, usability engineering, verification and validation.
• Exposure to interactions with notified bodies and regulatory authorities such as the US FDA, Health Canada and TGA is an asset.
• Ability to learn and adapt to new situations.
• 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.

Nice To Haves

• Bachelor’s degree in life sciences, biomedical engineering, or related discipline.

Responsibilities

• Support the maintenance of an ISO 13485, ISO 14971 and IEC 62304 -compliant quality management system.
• Support QMS processes such as CAPA, NCRs, customer complaints, internal audits, management reviews, and reviewing/updating SOPs.
• Assist in preparing, maintaining, and reviewing quality and regulatory documentation such as Quality Plans, Technical Files, Essential Requirements, regulatory strategy documents, product classification documents, Declarations of Conformity, Clinical Evaluation documents, and Post-Market Surveillance records.
• Support internal and external audits and related follow-up activities.
• Assist with reviewing labeling, IFUs, and marketing materials for compliance.
• Support interactions with regulatory authorities and notified bodies and supporting worldwide product registration including - Health Canada, FDA , TGA , MEDSAFE and EU.
• Support regulatory submissions.
• Assist in preparing AI/Software documentation.
• Contribute to Design History File (DHF) items, and ISO 14971 risk management and IEC 62304 software lifecycle documentation.

Benefits

• You’ll play a pivotal role in bringing transformative AI technology to global dermatology markets—helping physicians deliver faster, more accurate, and accessible care.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1-10 employees