Spécialiste affaires réglementaires

at  Motion Composites

QUALIFICATIONS :

• Diplôme universitaire dans un domaine technique, médical (un atout);
• Minimum 2 ans d’expérience dans un poste lié aux affaires réglementaires dans le domaine manufacturier ou médical, ou 5 ans dans un poste lié à l’assurance qualité;
• Expérience en assurance qualité et amélioration continue;
• Connaissance des réglementations du domaine médical au niveau international (FDA, MDR 2017/745, Santé Canada, GTA);
• Connaissance des processus de soumissions pour le remboursement par les instances tel que Medicare, CERAH (un atout);
• Connaissance des normes ISO 9001 et 13485;
• Bilinguisme écrit et oral;
• Excellente compétence en rédaction de documents techniques;
• Professionnalisme et rigueur, autonomie;
• Vivre les valeurs Motion.
  Le titulaire du poste pourrait être appelé à voyager occasionnellement.

ARE YOU LOOKING FOR A JOB IN A COMPANY THAT CONTRIBUTES TO A COLLECTIVE CAUSE? WOULD YOU LIKE TO TAKE PART IN THE INNOVATION OF AN EXCEPTIONAL VEHICLE?

Motion Composites is a young company that designs and manufactures ultra-light carbon folding wheelchairs. We distribute in 31 countries worldwide! In order to support our dream team, we are looking for people who want to live a rewarding work experience in line with our values:

• A desire to help others
• Show initiative
• Deliver sustainable results
• Communicate and work as part of a team
• Make it fun!

Under the supervision of the Regulatory Affairs and Quality Assurance Manager, the incumbent will provide support for the company’s regulatory compliance needs in the medical device manufacturing field.

RESPONSABILITIES :

• Collaborate with internal R&D, production and quality teams to ensure that products meet regulatory requirements prior to market release,
• Provide regulatory support throughout product development, ensuring compliance with national and international regulatory requirements,
• Coordinate activities and provide support for the implementation of various mandated regulatory projects for the various production sites,
• File submissions for product registration or approval with the various competent authorities,
• Maintain a constant regulatory watch,
• Support internal teams in implementing and maintaining a quality management system that complies with ISO 9001 and 13485 standards, as well as with the various applicable regulations,
• Conduct internal audits,
• Organize and execute external audits,
• Train internal teams on relevant regulatory changes,
• The incumbent may be required to travel occasionally.

QUALIFICATIONS :

• University degree in a technical or medical field, an asset;
• Minimum 2 years’ experience in a regulatory affairs position in the manufacturing or medical field, or 5 years in a quality assurance position;
• Experience in quality assurance and continuous improvement;
• Knowledge of submission processes for reimbursement by authorities such as Medicare, CERAH, an asset;
• Knowledge of international medical regulations (FDA, MDR 2017/745, Health Canada, GTA)
• Knowledge of ISO 9001 and 13485 standards;
• Bilingualism, written and spoken
• Excellent technical writing skills
• Professionalism and rigor, autonomy
  Type d’emploi : Temps plein, Permanent

Avantages :

• Assurance Dentaire
• Assurance Maladie Complémentaire
• Assurance Vie
• Assurance Vision
• Congés payés
• Cotisation égale au RÉER
• Événements d’Entreprise
• Heures d’arrivée et de départ flexibles
• Nourriture à Prix Réduit ou Gratuite
• Programme d’Aide aux Employés
• Stationnement sur place
• Tenue Décontractée
• Travail à domicile

Horaire :

• Du Lundi au Vendredi

Formation:

• Baccalauréat (Obligatoire)

Lieu du poste : En présentie

Please refer the Job description for details