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Qvella Corporation: Regulatory Affairs Manager

Qvella Corporation

This is a Full-time position in Gormley, ON posted January 29, 2021.

Job DescriptionAn exciting opportunity for a Regulatory Affairs Manager.

This is a permanent position with Qvella Corporation located in Richmond Hill, Ontario.

Position Summary:Responsible for pre and post-market compliance with regulatory requirements pertaining to IVD medical devices designed and manufactured at Qvella.Essential Duties and Responsibilities:Plan and draft regulatory strategy for new and existing products in line with corporate vision, and identify clinical, technical or operational risks that may impact the success of regulatory filings and approvals; Interact with R& D team in preparing pre-submission dossiers (Q-sub), assisting in the planning of validation studies and conducting risk management; Prepare and file premarket applications (e.G.: 510(k), new medical device applications, CE marking) to regulatory agencies and EU Notified Body; Liaise with regulatory agencies/Notified Body during pre-market review and audits/inspections; Facilitate the transition and implement the new EU IVD Regulation; Review and approval of labeling, including promotional materials and claims; Draft and revise procedures, instructions and forms related to regulatory affairs; Conduct regulatory impact assessment of post-market changes to devices and file amendment to regulatory agencies when required; Implement and maintain the UDI program in identified markets; Investigate complaints, potential recalls, adverse events and determine reportability; notify and interact with agencies when requiredAssist Product Development department in maintaining product safety/electrical/EMC compliance; Participate in cross-functional meetings when regulatory assistance is required (supplier review board, product disposition review, labeling review, etc.); Perform internal audits and suppliers’ audits as planned; Other duties asrequired.Other Job Requirements:Excellent knowledge of ISO 13485:2016 and MDSAP requirements; Excellent knowledge of FDA, Health Canada and EU regulations, standards, guidance documents, and directives pertaining to the IVD medical device industry; Strong knowledge of GHS, symbols and labeling requirements for IVD products; Strong knowledge of advertising and promotion of medical devices; May include travel, when necessary (audit).Experience/Qualifications:Hands-on experience in regulatory affairs in the medical device industry, including interactions with the FDA and Health Canada; Experience filing Q-sub and 510(k) applications with the FDA is a must; Experience submitting medical device applications to Health Canada preferred; Demonstrated success within a start up, entrepreneurial work environment; Highly organized, meticulous and capable of multi-tasking various projects/timelines at one specific time; Excellent oral and written communication skills (English); Process oriented, logical, analytical, problem solving; able to analyze data and implement solutions; Strong interpersonal skills and teamwork approach; motivated to achieve goals; Preferences will be given to candidates with certifications (ASQ, RAPS).Education:Minimum B.Sc.

with at least 5 years of experience in Regulatory Affairs or a closely related discipline.

Or advanced degree in Molecular Biology or a related discipline with 3-5 years experience.

What are you waiting for?

Apply Now!Qvella is an equal opportunity employer.

We are committed to a diverse and inclusive workplace for all.

If you are selected to participate in the recruitment process, please inform us of any accommodations you may require.

Qvella will work with you in an effort to ensure that you are able to fully participate in the process.

All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.Must be legally eligible to work in Canada at the location(s) specified above and, where applicable, must have a valid work permit or study permit that allows the candidate to fulfill the requirements of the role.We thank all interested applicants; however, only those selected for an interview will be contacted.Powered by JazzHRg3J0vFBfbb