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Regulatory Affairs Specialist

Job Number:
J0321-0003
Job Type:
Full Time
Job Category:
Science
Location:
Montreal, Quebec
Salary:
Open

Regulatory Affairs Specialist

Status: Permanent full-time
Location: Toronto, ON (GTA)
Note: Client is open to candidates working remotely from Montreal, QC
Compensation: Competitive salary based on experience and group insurance benefits plan

PLEASE SEND YOUR CV TO CAROLE.VIGER@GROOMASSOCIES.COM

We thank all candidates for showing interest in this role; however, only retained candidates will be contacted.

For more information on our recruitment services, please visit our website www.groomassocies.com

Summary:
The Regulatory Affairs Specialist will be responsible for providing the regulatory issues that impact the company. The incumbent will provide direction and recommendations for the active management and interpretation of regulatory issues discussing with headquarter RA and QA teams. She/he will function as the key liaison to meet compliance obligations of domestic
regulatory agencies and applicable regulatory bodies (Health Canada).

Responsibilities:

• Participate in the creation, development and implementation of regulatory strategies for newly developed products; compile information and data pertaining to regulatory and project requirements, consult external authorities to confirm the strategy identifies the project’s objectives and analyzes risks;
• Assist in creating submissions including pre-submissions, initial submissions, change notifications, amendments to Health Canada
• Write, analyze, and edit technical documents to support Canadian specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents.
• Actively review new Canadian standards/regulatory updates and communicate pertinent information. Analyze analytical studies and clinical trial data.
• Review and provide input into marketing/sales materials to ensure compliance with the governing regulations and company procedures.
• Assess customer complaints for regulatory reporting of adverse events.
• Prepare annual reports and renewal submissions to various regulatory jurisdictions.
• Undertake any other regulatory tasks as required.
• Undergo training to participate in an Internal Audit program

Education / Experience
• Bachelor degree or equivalent in life sciences.
• 1 - 3 years on the job experience in Regulatory/Quality or other related disciplines in the medical device/ pharmaceutical/ biologics industry.
• Knowledge of medical device regulations in Canada, and good understanding of ISO 9001 required.
• Working knowledge of the MS Office suite and Adobe required.
• Experience liaising with Regulatory Authorities i.e. Health Canada, Notified Bodies is an asset
• Medical Device Regulatory or Quality certifications will be an asset.
• Demonstrated exceptional organizational skills
• Good communication skills, both written and oral
• Effectively manage priorities to meet timelines.

Key Contacts:

• Reports directly to Regulatory Affairs Manager
• Works closely with the corporate QA/R&D/Marketing department
• Regular interaction with local senior staff

Votre partenaire en recrutement – Your recruitment partner www.groomassocies.com