Manager, Regulatory Affairs

An exciting opportunity for a **Manager, Regulatory Affairs**. This is a permanent position with Qvella Corporation located in Richmond Hill, ON.

**Nature and Scope of Work**:
Responsible for pre
- and post-market compliance with regulatory requirements pertaining to IVD medical devices designed, developed and manufactured at Qvella for distribution in target markets. Assist in regulatory strategies for growth opportunities and product development per business priorities.

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;
- Collaborate with R&D team in preparing pre-submission dossiers (Q-sub), assisting in the planning of validation studies and conducting risk management;
- Ensure devices are only distributed in jurisdictions where market authorization has been obtained;
- Liaise with regulatory agencies/Notified Body during pre-market review and audits/inspections;
- Develop and implement strategies and plans of action to address changes in the regulations; participate in the transition and implementation of the new EU IVD Regulation;
- Review and approval of labeling, including promotional materials and claims;
- Support the commercial team in ensuring appropriate language pertaining to regulated devices is used when interfacing with customers and distributors;
- 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 required;
- Assist in maintaining product safety/electrical/EMC compliance and related certifications;
- Participate in cross-functional meetings when regulatory assistance is required (supplier review board, product disposition review, labeling review, etc.);
- Assist Quality Assurance in performing internal audits and suppliers’ audits as planned;
- Other related duties as required.

**Qualifications and Requirements**:

- Strong knowledge of US, Canada and EU regulatory requirements pertaining to IVD devices, as well as MDSAP and ISO 13485: 2016
- Proven track record in a start up working environment in IVD industry;
- Strong leadership and managerial skills in leading cross-functional teams and providing regulatory expertise to internal and external stakeholders
- Be able to work independently, strong sense of accountability and motivated to achieve goals
- In-depth understanding of emerging trends and issues in the changing regulatory landscape;
- Highly organized, meticulous and capable of multi-tasking various projects/timelines at one specific time;
- Excellent oral and written communication skills in English
- Process oriented, logical, analytical, problem solving; able to analyze data and implement solutions;
**Education**:

- Minimum B.Sc. in molecular biology, chemistry, or related discipline with at least 3 years of experience in regulatory affairs.

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.

We thank all interested applicants; however, only those selected for an interview will be contacted.

n1nUVA5J8b