An exciting opportunity for Director, Regulatory Affairs and Quality Assurance. This is a permanent position with Qvella Corporation located in either: Richmond Hill, Ontario, Canada, California, or North Carolina. Nature and Scope of Work Responsible for maintaining ISO 13485 Quality Management System to ensure suitability, adequacy and effectiveness in accordance with company\xe2\x80\x99s quality manual and procedures. Ensure regulatory compliance and oversee the regulatory strategies for growth opportunities and product development in alignment with business priorities. Essential Duties and Responsibilities To perform this job successfully, an individual must be able to perform each essential duty:

• Ensure compliance to ISO 13485 quality standards and applicable regulatory requirements pertaining to the IVD medical device industry (FDA, Health Canada, CE and foreign markets)
• Analyze data to identify areas for improvement in the quality processes
• Prepare, review and implement new SOPs and ensure ongoing staff training
• Conduct formal internal/supplier audit for ISO, cGMP and regulatory compliance
• Work effectively work product development and production teams to develop process control/validation protocols
• Investigate customer complaints and non-conforming issues
• Recommend and monitor corrective and preventive actions
• Assist management representative in the preparation for annual ISO quality system audit and external audits
• Provide leadership in the preparation and development of worldwide registration and approval activities for getting company\xe2\x80\x99s product into the market
• Develop regulatory strategies with respect to IVD device regulatory requirements, risk management, registration, and product safety testing standards
• Perform regulatory due diligence, proactively identify business impact and opportunities in the regulatory environment
• Lead and manage the preparation, compilation and assembly of submission documents to regulatory bodies including FDA, CE and Health Canada
• Identify major clinical, technical, or operational risks impacting on the success of regulatory filing, approvals, labeling and maintenance
• Responsible for the development and maintenance of excellent working relationship with regulatory bodies and industry associations
• Work closely with R&D team with respect to regulatory submissions and negotiations
• Work closely with marketing team to integrate KOL insights into regulatory strategy and to contribute to business initiatives

Qualifications and Requirements

• At least 10 years of Regulatory Affairs and Quality Systems management experience within the medical device or pharmaceutical industry (molecular diagnostics preferable)
• Hands-on experience in ISO QMS implementation and maintenance
• In-depth understanding of emerging trends and issues in the changing regulatory landscape
• Hands-on expertise and applied knowledge of FDA, CE and Health Canada regulations for medical device industry IVD device
• Experience with regulatory filings (510(k), Health Canada applications, CE marking, international registrations)
• Experience in supervisory and managerial positions
• Strong analytical skills in risk assessment and management coupled with sound business judgment
• Must possess excellent strategic, organizational and presentation skills
• Excellent written and verbal communication skills
• Excellent ability to build and maintain strong and collaborative working relationships with internal and external contacts
• Ability to work independently in a fast-paced environment with rapidly changing priorities
• Organized, attentive to detail and able to prioritize and handle multiple projects with competing deadlines
• Problem solving \xe2\x80\x93 identifies complex problems and reviews related information to develop and evaluate options and implement solutions
• Process management \xe2\x80\x93 ability to simplify complex processes and to organize people and activities
• Travel may be required, when necessary (audit)

Education

• Minimum Bachelor Degree in Science or related field, or experience demonstrating equivalent required knowledge and competencies.
• Certification in a regulatory or quality discipline preferred, such as RAC, ASQ Certified Quality Auditor/Engineer, Quality Manager, etc.

In support of our commitment to a healthy and safe workplace, Qvella Corporation has a vaccination requirement as a condition to the offer of employment. Fully vaccinated is defined as having received a completed series of an accepted COVID-19 vaccine, as recommended or approved by Health Canada and having received the final dose at least 14 days before your employment start date. Ongoing boosters may be required in the future as a continuing condition of employment, as they are announced by Health Canada. We will provide a full copy of our policy at the time of offer. The candidate will be asked to provide Qvella with proof of full vaccination, prior to their employment start date. Acceptable proof is a Ministry of Health Dose Administration Receipt. This can be obtained through the Provincial portal at https://covid19.ontariohealth.ca/. We will also accept out of province vaccination records, provided they have the same information included in the Ministry of Health Dose Administration Receipt. This includes the type of vaccine, date of each dose and sufficient identification information to connect the receipt to the candidate. The requirement to be fully vaccinated is subject to the Ontario Human Rights Code. If the candidate is unable to vaccinate for a reason protected by the Code, a request for accommodation can be made upon written proof, satisfactory to the company.
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. oVL3cn53YQ