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Regulatory affairs associate Jobs in Cambridge on

Last updated: 1 day ago
Regulatory Affairs Associate (20-Month Mat Leave Contract)

Regulatory Affairs Associate (20-Month Mat Leave Contract)

Clarion Medical Technologies Inc.Cambridge, Ontario, Canada
Show moreLast updated: 18 days ago
Product and Process Specialist

Product and Process Specialist

Sunrise FarmsCambridge, Ontario
Full-time
Show moreLast updated: 6 days ago
Sales Associate

Sales Associate

Tbooth wirelessCambridge, Ontario, Canada
Full-time
Show moreLast updated: 1 day ago
  • Promoted
Delivery Support Associate

Delivery Support Associate

RONA+Cambridge, ON, Canada
Full-time
Show moreLast updated: 18 days ago
Membership Sales Associate

Membership Sales Associate

Orangetheory Fitness 10096Cambridge, ON, CA
CAD15.5–CAD22 hourly
Part-time
Show moreLast updated: 30+ days ago
Sales Associate

Sales Associate

Rogers CommunicationsCambridge, ON, CA
Show moreLast updated: 12 days ago
Specialist IS Analyst

Specialist IS Analyst

Aditi ConsultingCambridge, CA
CAD45–CAD49 hourly
Show moreLast updated: 30+ days ago
Sales Associate

Sales Associate

RogersCambridge, Ontario, Canada
Show moreLast updated: 11 days ago
  • Promoted
Access Services Associate

Access Services Associate

InsideHigherEdCambridge, Ontario, Canada
CAD63259 yearly
Full-time
Show moreLast updated: 1 day ago
Accounts Payable Associate

Accounts Payable Associate

SeptodontCambridge, Canada
CAD20 hourly
16 months
Show moreLast updated: 30+ days ago
  • Promoted
Underwriting & Product Associate

Underwriting & Product Associate

Farm Mutual ReCambridge, Ontario, Canada
Full-time
Show moreLast updated: 5 days ago
Junior Finance Associate

Junior Finance Associate

Elby Professional Recruitment IncCambridge, ON, CA
CAD45000–CAD47000 yearly
Permanent
Quick Apply
Show moreLast updated: 25 days ago
Sales Floor Associate

Sales Floor Associate

SaversCambridge, ON
CAD17 hourly
Full-time
Show moreLast updated: 30+ days ago
Sales Associate - Spencer's

Sales Associate - Spencer's

Spencer'sCambridge, ON
CAD15.75–CAD17.56 hourly
Part-Time
Show moreLast updated: 30+ days ago
Vice President, Legal Affairs and Risk Management - Hybrid

Vice President, Legal Affairs and Risk Management - Hybrid

Cowan Insurance GroupCambridge, ON, CA
CAD100000–CAD150000 yearly
Full-time
Show moreLast updated: 30+ days ago
Sales Associate

Sales Associate

StructubeCambridge, ON
CAD16 hourly
Full-time
Show moreLast updated: 30+ days ago
Sales Associate - Spirit

Sales Associate - Spirit

Spirit HalloweenCambridge, ON
CAD15.75–CAD17.56 hourly
Full-Time
Show moreLast updated: 30+ days ago
FT Associate, Asset Protection

FT Associate, Asset Protection

Hudson’s Bay: cambridge, ontario, canada
CAD20 hourly
Show moreLast updated: 30+ days ago
Merchandise Processing Associate

Merchandise Processing Associate

Savers / Value VillageCambridge, ON, CA
Show moreLast updated: 18 days ago
Seasonal Associate - CR1124

Seasonal Associate - CR1124

Genuine Canadian CorporationCambridge, ON
CAD16 hourly
Part-time
Show moreLast updated: 30+ days ago
Regulatory Affairs Associate (20-Month Mat Leave Contract)

Regulatory Affairs Associate (20-Month Mat Leave Contract)

Clarion Medical Technologies Inc.Cambridge, Ontario, Canada
18 days ago
Job description

Clarion Medical Technologies, a Richards Packaging company, specializes in surgical, vision and aesthetic healthcare medical devices. Some of these products include laser technologies, diagnostic tools for early disease detection and advanced imaging systems. At Clarion, we are dedicated to empowering healthcare providers with the tools and expertise to deliver outstanding patient outcomes, while shaping the future of medical technology and aesthetics in Canada.

Why join Clarion :

  • Generous compensation package including a competitive base salary and variable compensation
  • Fantastic extended healthcare benefits for you and your family
  • Paid vacation time and personal days
  • Monday-Friday day shift operations with work / life balance at the forefront
  • Lunch & learns, volunteer time and a focus on supporting our community
  • Collaborative, open concept office
  • And so much more!

About the Role :

Reporting to the Senior Director of Regulatory Affairs and Quality Compliance, the Regulatory Affairs Associate will be responsible for ensuring all regulatory submissions, documentation, and compliance activities are executed with precision. You will play a vital role in supporting key quality system projects, managing product documentation, and ensuring post-market compliance for our medical devices. This position is ideal for someone with a strong background in regulatory affairs and quality compliance, with a keen eye for detail and a passion for maintaining high standards.

This is a temporary full-time, 20-month maternity leave, contract with potential for extension.

The successful applicant will :

  • Prepare and register regulatory submissions for new product registrations, ensuring compliance with Health Products and Food Branch (HPB) guidelines and other regulatory requirements.
  • Manage scientific, medical, clinical, and manufacturing documentation related to product registration and quality compliance.
  • Facilitate eQMS (electronic Quality Management System) records for product changes, government requests, and affiliate interactions.
  • Lead key quality system projects, including complaint handling, traceability, technical file / batch work processing, and receiving inspections.
  • Ensure suppliers provide documentation and responses within specified limits, adhering to regulatory and quality standards.
  • Investigate and analyze regulatory and quality issues, providing technical support and resolutions.
  • Maintain document control, including specifications and quality databases, ensuring all documents meet regulatory requirements.
  • Monitor and analyze process and quality data to identify trends, assess risks, and ensure compliance with quality programs.
  • Collect, process, and analyze data related to complaint handling, adverse events, and mandatory reporting.
  • Ensure continual improvement and effectiveness of corporate quality systems (ISO, MDSAP, MDD / MDR, GMP) and maintain compliance with annual audits and regulatory requirements.
  • Support post-market compliance for obtained medical device licenses and assist in new product approvals (Canada, FDA, EU).
  • Help maintain the effectiveness of the eQMS platform.
  • We are seeking a candidate with the following experience and attributes :

  • Bachelor's degree (BA) in Life Sciences, Medical Technology, Regulatory Affairs, or a related field.
  • Minimum of 3 years of experience in a regulatory affairs or quality compliance role, preferably within the medical device or pharmaceutical industry.
  • Strong analytical skills and attention to detail.
  • Expertise in regulatory and quality management software and systems.
  • In-depth knowledge of medical device regulations, including ISO, MDSAP, MDD / MDR, GMP.
  • Excellent research, problem-solving, and communication skills.
  • Ability to collaborate with cross-functional teams and external stakeholders to achieve regulatory and quality goals.
  • Clarion Medial Technologies is an equal-opportunity employer and is committed to creating an inclusive employee experience for all. We firmly believe that our work is at its best when everyone feels free to be their most authentic self. If you require accommodation, please let us know how we can further support you during the recruitment process.