Regulatory Affairs Specialist Jobs Vacancy in Conavi Medical North York
Conavi Medical North York urgently required following position for Regulatory Affairs Specialist. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.
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Regulatory Affairs Specialist Jobs Vacancy in Conavi Medical North York Jobs Details:
Conavi Medical is a medical device company developing solutions to improve care for patients with cardiac arrhythmias, structural heart disease and coronary artery disease. We are focused on developing innovative technologies to guide minimally-invasive procedures by miniaturizing imaging systems designed to be introduced into the body. We are currently in a growth stage and are looking for people who are excited about contributing to the success of healthcare and who are willing to work diligently at having significant positive impact on the millions of people affected by serious heart and vascular conditions globally.
We are currently recruiting a Regulatory Affairs Specialist to join our multidisciplinary team of over 70 people based out of our facility in Toronto. Reporting to the Director, Quality and Regulatory, this is an exceptional opportunity for a talented individual who is ambitious, hardworking, and wants to contribute to the future of healthcare at an international scale.
MAIN JOB RESPONSIBILITIES
Review quality, preclinical and clinical documentation and records for submission of regulatory applications to global jurisdictions (i.e. U.S., Canada, Europe, Japan, China)
Compile documentation and prepare medical device regulatory applications for submission to global regulatory agencies
Manage communications with regulatory agencies and external partners managing regulatory submissions on behalf of the organization
Provide regulatory review of product design, product changes and quality management system documentation (including policies, procedures, documents and records)
Maintain and update device listings, device licenses, CE technical files and establishment registrations
Monitor markets for regulatory changes to applicable regulations and requirements and communicate changes across the organization.
Provide regular reports to management on the status of regulatory submissions, licenses/clearances and registrations
Support quality management system and regulatory compliance activities as needed (e.g. change control, audits)
EDUCATION AND QUALIFICATIONS
Bachelor’s degree in Science or Engineering
3-5 years’ experience working with regulatory submissions in the medical device industry
Experience with regulatory submissions in global jurisdictions (e.g. U.S., Canada, Europe, Asia-Pacific)
Working knowledge of global regulations (e.g. FDA, Health Canada, EU, Japan PMDA, China SFDA)
Strong documentation and presentation skills
Post-graduate diploma in Regulatory Affairs an asset
General computer knowledge including proficiency with Microsoft Word, Excel, and e-mail
Strong organizational skills and attention to detail
Ability to multi-task, prioritize duties and execute tasks in a timely manner
Strong self-initiative and work ethic
Conavi Medical values diversity and encourages applications from all qualified candidates including women, visible minorities, Aboriginal peoples, and persons with disabilities.
Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.
Please submit a cover letter and resume by the application deadline, February 12, 2018 . We thank all candidates for their interest but only those selected for an interview will be contacted.