Regulatory Affairs Specialist
Ville de Québec
TSO3 is a publicly traded company listed on the Toronto Stock Exchange (TOS), with offices in Québec City. Its activities cover sales, maintenance, production, research, development, and the granting of licenses of sterilization processes, accessories and related consumables for heat-sensitive medical devices. The technology has a combination of unique features in low temperature sterilization industry, which advantageously position it against the competition in this fast-growing sector. In December 2014, TSO3 has received approval from the Food and Drug Administration (FDA) for the commercialization in the US of its new STERIZONE® VP4 Sterilizers.
Join a team dedicated To Create and Deliver the New Standard of Care in Sterile Reprocessing TM
To support its current operations and future growth, TSO3 is seeking to hire a Regulatory Affairs Specialist
Under the supervision of the Regulatory Affairs and Quality Assurance Director, the incumbent manages the post market surveillance (PMS) process according to the Canadian, European, US and other applicable regulation for the TSO3 medical device applications. The PMS part of the position includes complaints handling, investigation management for the products manufactured at the different location of TSO3. The Regulatory Affairs Specialist is also responsible to handle requests from marketing department on product registration of medical devices into new or existing markets. In that role, The Regulatory Affairs specialist must be able to gather and develop the necessary documentation to allow smooth and effective device registration to the relevant regulatory agencies or distribution partners. The Regulatory Affairs specialist also supports the R&D and engineering group as a project member and act as regulatory representative for the company.
- Manage post market surveillance workload
- Evaluate and escalate reportable events as identified
- Maintain regulatory databases such as customer complaints and produce various reports as necessary
- Knowledge of statistical trending and analysis
- Working understanding of domestic and international medical device regulation
- Participate in New Product Development cross-functional teams as the RA core team member
- Review product labeling for compliance with global labeling regulations
- Review product change requests and notifications for assessment to regulatory impact to licenses
- Support the preparation, submission and maintenance of global product registrations with a focus on U.S. 510(k) and EU technical files
- Collaborate with the different stakeholder to obtain and understand registration requirements
- Create and maintain key performance indicators (KPI) and reports
- BA or BS degree in a technical discipline (e.g. Engineering. Marketing/product commercialization or law discipline)
- Experience: Minimum 3 years of experience, including a minimum of two (2) years of experience in Regulatory Affairs or Regulatory Affairs /Quality Assurance field combined
- Experience in a medical device or other highly regulated industry
- Languages: advanced level of French and English (oral and written)
- Organized, self-directed, rigorous, good problem solver and team oriented
- Demonstrated project management and/or organizational skills
- Ability to define clear user, regulatory and technical requirements addressing stakeholders needs
- Ability to link information from various sources and/or disciplines
- International registration experience preferred
- Must be able to travel internationally
Many benefits await you
- Competitive salary
- Full group insurance including dental care
- Stock purchase plan
- Group RRSP
- Additional benefits
We thank you for your interest in TSO3. Please take note that we only communicate with the candidates retained for an interview.
TSO3 is an equal opportunity employer.
How to apply?
Send us your resume by:
Fax: (418) 653-5726
2505, avenue Dalton, Québec (Québec)
CANADA G1P 3S5