Quality and Regulatory Affairs Associate
About the position
Dandy is hiring a detail-oriented Quality and Regulatory Affairs Associate to join our rapidly growing venture-backed company. The Quality team owns Quality and Compliance. In this role, you’ll help execute regulatory requirements for Canada, the UK, and Europe, while supporting an ISO 13485-compliant Quality Management System (QMS) and MDSAP readiness. You will also contribute to post-production quality activities such as post - market surveillance, CAPA support, and document control within an electronic QMS (eQMS). The role is an exciting opportunity to implement and improve quality and compliance at a fast paced company.
Responsibilities
• Regulatory Execution: Support registrations, submissions, and lifecycle maintenance activities required to commercialize and maintain products in Canada, the UK, and Europe (e.g., Health Canada, UK MHRA/UKCA, EU MDR).
• Technical Documentation: Compile, format, and maintain technical documentation and submission-ready records (e.g., labeling, risk management file inputs, design and manufacturing information, performance evidence) in collaboration with cross-functional teams.
• Regulatory Intelligence: Monitor regulatory changes and guidance updates; summarize impacts and propose updates to internal processes, labeling, or documentation as needed.
• Notified Body / External Partner Support: Coordinate information requests and document retrieval for external reviewers (e.g., Notified Body, MDSAP Auditing Organization, authorized representatives).
• QMS Support: Help maintain and improve QMS processes and records to support ISO 13485 certification and ongoing compliance.
• Audit Readiness & Support: Support internal and external audits by preparing objective evidence, retrieving records, and assisting with responses to audit observations.
• Training & Records: Support training assignments, effectiveness documentation, and maintenance of compliance records in the eQMS.
• Document Control: Create, format, route, and maintain controlled documents (SOPs, work instructions, forms, and records) in the eQMS, including version control, periodic review, and archival of obsolete documents.
• eQMS Support: Support user access, templates, and day-to-day system workflows (e.g., document control, CAPA, training) to ensure data integrity and inspection readiness.
• Complaint Handling: Receive, log, review, and route product complaints for investigation; ensure timely, complete, and compliant documentation and closure.
• Escalation & Reporting Support: Support evaluation of complaint severity and potential reportability; assist with documentation for vigilance, safety reporting, and field actions per applicable regulations and procedures.
• Trending: Support analysis and trending of complaints and post-market data; communicate signals and feed learnings into CAPA, risk management, and continuous improvement activities.
Requirements
• Education: Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related field.
• Experience: 2–3 years of experience in Quality Assurance and/or Regulatory Affairs within the medical device (or other regulated) industry.
• Standards & Regulations: Working knowledge of ISO 13485 and familiarity with MDSAP expectations; exposure to EU MDR, UK (MHRA/UKCA), and/or Health Canada requirements is a plus.
• Core Regulatory Skills: Experience with supporting technical documentation or submissions to a regulatory body.
• Soft Skills: Strong technical writing, organization, attention to detail, and the ability to manage multiple priorities across teams.
Nice-to-haves
• International regulatory exposure: any exposure to EU MDR, UK MHRA/UKCA, and/or Health Canada requirements (this is listed as “a plus”)
• Audit readiness experience: familiarity supporting ISO/MDSAP audits (prep objective evidence, respond to audit observations).
• Multi-site QMS support: experience supporting a QMS across multiple sites/locations.
Benefits
• Competitive salary and comprehensive benefits including healthcare, dental, mental health support, and retirement savings options
Apply Now
Apply Now
Dandy is hiring a detail-oriented Quality and Regulatory Affairs Associate to join our rapidly growing venture-backed company. The Quality team owns Quality and Compliance. In this role, you’ll help execute regulatory requirements for Canada, the UK, and Europe, while supporting an ISO 13485-compliant Quality Management System (QMS) and MDSAP readiness. You will also contribute to post-production quality activities such as post - market surveillance, CAPA support, and document control within an electronic QMS (eQMS). The role is an exciting opportunity to implement and improve quality and compliance at a fast paced company.
Responsibilities
• Regulatory Execution: Support registrations, submissions, and lifecycle maintenance activities required to commercialize and maintain products in Canada, the UK, and Europe (e.g., Health Canada, UK MHRA/UKCA, EU MDR).
• Technical Documentation: Compile, format, and maintain technical documentation and submission-ready records (e.g., labeling, risk management file inputs, design and manufacturing information, performance evidence) in collaboration with cross-functional teams.
• Regulatory Intelligence: Monitor regulatory changes and guidance updates; summarize impacts and propose updates to internal processes, labeling, or documentation as needed.
• Notified Body / External Partner Support: Coordinate information requests and document retrieval for external reviewers (e.g., Notified Body, MDSAP Auditing Organization, authorized representatives).
• QMS Support: Help maintain and improve QMS processes and records to support ISO 13485 certification and ongoing compliance.
• Audit Readiness & Support: Support internal and external audits by preparing objective evidence, retrieving records, and assisting with responses to audit observations.
• Training & Records: Support training assignments, effectiveness documentation, and maintenance of compliance records in the eQMS.
• Document Control: Create, format, route, and maintain controlled documents (SOPs, work instructions, forms, and records) in the eQMS, including version control, periodic review, and archival of obsolete documents.
• eQMS Support: Support user access, templates, and day-to-day system workflows (e.g., document control, CAPA, training) to ensure data integrity and inspection readiness.
• Complaint Handling: Receive, log, review, and route product complaints for investigation; ensure timely, complete, and compliant documentation and closure.
• Escalation & Reporting Support: Support evaluation of complaint severity and potential reportability; assist with documentation for vigilance, safety reporting, and field actions per applicable regulations and procedures.
• Trending: Support analysis and trending of complaints and post-market data; communicate signals and feed learnings into CAPA, risk management, and continuous improvement activities.
Requirements
• Education: Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related field.
• Experience: 2–3 years of experience in Quality Assurance and/or Regulatory Affairs within the medical device (or other regulated) industry.
• Standards & Regulations: Working knowledge of ISO 13485 and familiarity with MDSAP expectations; exposure to EU MDR, UK (MHRA/UKCA), and/or Health Canada requirements is a plus.
• Core Regulatory Skills: Experience with supporting technical documentation or submissions to a regulatory body.
• Soft Skills: Strong technical writing, organization, attention to detail, and the ability to manage multiple priorities across teams.
Nice-to-haves
• International regulatory exposure: any exposure to EU MDR, UK MHRA/UKCA, and/or Health Canada requirements (this is listed as “a plus”)
• Audit readiness experience: familiarity supporting ISO/MDSAP audits (prep objective evidence, respond to audit observations).
• Multi-site QMS support: experience supporting a QMS across multiple sites/locations.
Benefits
• Competitive salary and comprehensive benefits including healthcare, dental, mental health support, and retirement savings options
Apply Now
Apply Now