Regulatory Affairs and Quality Assurance Lead

The Company is part of the Diploma Healthcare Group (DHG) which is a group of specialized medical device distribution companies operating in Canada, Australia, New Zealand and Ireland. DHG is owned by Diploma PLC, a public company traded on the London Stock Exchange with a market cap in excess of £1.1B.

**Somagen Diagnostics Inc.** was founded +30 years ago in Edmonton and has grown steadily to become Canada’s largest independent provider of medical diagnostic technology to laboratories, hospitals and clinics. Somagen is the exclusive Canadian distributor for many of the world’s most respected diagnostic product suppliers such as Polymedco, Phadia, and Sakura. We pride ourselves on being a highly technical sales organization providing leading support solutions to our clinical customers. Our proven business model has consistently achieved sustained growth even through challenging economic times.

**Vantage Endoscopy and AMT Surgical** are leading sales focused distribution organizations specializing in high tech niche diagnostic and therapeutic medical products focused on Endoscopy/GI Suite, GI Clinics and Hospital Operating Rooms across Canada.

Representing suppliers of innovative diagnostic and therapeutic products devices from around the world, we are a leader in medical product and device distribution in Canada.

**What you’ll do**:
In this exciting role you will be responsible for ensuring compliance with applicable laws, regulations, and industry standards. You will play a crucial role in managing and/or providing regulatory guidance to internal and external stakeholders for all aspects of the distribution environment for medical devices such as:

- Act as single point of contact for regulatory issues and drive items to resolution within the organization;
- Overseeing product complaint handling and assessment of device related incidents/complaints for medical device reporting requirements and applicable Health Canada reporting timelines
- Submission of MDPR (Medical Device Problem Reporting) to Health Canada if applicable
- Coordination of recalls with customers, suppliers and Health Canada
- Ensure compliance of products and processes with Health Canada regulations including but not limited to thorough reviews of product labeling, advertising materials and promotional activities.
- Prepare and compile regulatory submissions, responses to regulatory agency questions and other correspondence. Responsible for the preparation and assigning of product attributes of electronic documents for publishing to support regulatory submissions.
- Maintain regulatory files/database and chronologies in good order. Establish and maintain the system for tracking changes in documents submitted to agencies or partners;
- Research/Identify product licensing requirements and regulatory classification
- Assists select suppliers with Health Canada Medical Device License Applications
- Renewal and/or amendment of Health Canada Medical Device Establishment License (MDEL) and collaborate with internal stakeholders to develop and update standard operating procedures (SOPs) to ensure compliance with regulatory standards.
- Maintain regulatory files/database and chronologies in good order. Establish and maintain the system for tracking changes in documents submitted to agencies or partners;
- Stay current with regulatory (i.e., Health Canada, global) trends, changes and evolving requirements and proactively communicate updates internally, and to suppliers ensuring awareness and adherence to relevant regulations.
- Interact with regulatory authorities, industry associations, and external consultants to stay updated on best practices and regulatory changes.
- Lead the company in meetings, audits, inspections and other regulatory interactions.
- As the position evolves, you will also lead the companies’ Internal controls, which includes evaluating and documenting current systems, processes and procedures.
- Assist in evaluating and documenting needs related to process improvements or enhancements; may prepare training documentation or assist in training of users for quality or regulatory purposes
- Recommend best audit, internal control and process improvements,
- In the future, support the implementation of a quality management certification (including ISO program).

**Requirements**:
The successful individual will possess the following skills and qualifications:

- Excellent verbal and written business level communication skills in English are a must
- Bachelor’s degree in life science or relevant scientific field, additional Master of Science in Regulatory Affairs or Regulatory Affairs Certification preferred
- Preferably, have a minimum of 3-5 years of experience with Health Canada, Medical Devices Regulations. Regulatory Administration, Product Complaint Handling, and/or SOP implementation in a Distribution environment are a definite asset
- Experience reading, understanding and interpreting codes, standards, regulat