Senior Regulatory Affairs Analyst Jobs in British Columbia

Intermediate project management, time management and organizational skills

4 -10 years’ related experience and/or training or equivalent combination of education and experience

Advanced knowledge of the electricity regulated industry or equivalent experience with emphasis on rate design and cost allocation methodologies

Intermediate knowledge of Occupational Health and Safety requirements as it relates to individual, organizational and operational requirements

Senior Manager of Regulatory Affairs and Risk Management.

8 years’ experience in a supervisory role

Experience working within a Quality Management System (QMS)

Strong organizational, time management, and prioritization skills.

Support system administration of Quality Management System software.

Skills and Experience to Enable Success:

A continuous learner that builds on their existing knowledge of medical device and biomedical technology regulations

Collaborate with cross-functional teams and interface with external parties to meet quality requirements within project timelines.

Be a valuable member of our risk management team, contributing from a regulatory perspective to risk assessment exercises and documents

Build partnerships, internally and externally, to provide routine updates and ensure compliance with regulatory requirements

A minimum of 3 years of experience in regulatory affairs within the medical device or life sciences industry

Proven experience in compiling and submitting pre-market regulatory submissions, such as 510(k), De novo, and IVDR Technical Documentation

Collaborate with cross-functional teams to provide regulatory inputs during the design and development phase of our devices

Compile pre-market submissions, including pre-submissions, 510(k), De novo, and IVDR Technical Documentation as necessary