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Regulatory & Quality Associate

3 months ago

Halifax, Canada Adaptiiv Medical Technologies Full time

At Adaptiiv Medical Technologies Inc., we help transform the patient experience with 3D printed patient-specific accessories for use in radiation therapy. We foster a culture of innovation, collaboration, diversity, creativity, growth, and success. We are always looking for individuals who have exceptional talent and an entrepreneurial drive to contribute to the ongoing fight against cancer.

If you are passionate about making a difference, we want you on our team

**REGULATORY & QUALITY ASSOCIATE**

Adaptiiv is looking for a Regulatory & Quality Associate to join our growing Regulatory team, as we scale and launch our products and services to market.

Reporting to the Business Operations Manager, the Regulatory & Quality Associate supports Adaptiiv’s regulatory activities to achieve and maintain product registration and certification globally. Working as a key member of the team, the Regulatory & Quality Associate provides support for all facets of the regulatory process, preparing submissions, providing guidance to commercialization, overseeing the Quality Management System, performing risk management, and reporting activities.

**What You’ll Be Doing**
- Support regulatory activities related to product registrations in North America, Europe, Australia, and New Zealand.
- Review and provide input into marketing, commercialization, and sales materials to ensure compliance with corresponding governing regulations and company procedures.
- Assist in preparation of annual post-market safety reports and post-market clinical follow ups.
- Actively review new external standards/regulations and communicate pertinent information.
- Update required master document indices on a regular basis.
- Participate in the Internal Audit program as an Internal Auditor and assist Management Representative during external Quality System audits.
- Work with various departments to conduct required risk management activities and provide quality assurance support.
- Assist with initiation and follow up of Nonconformity Reports (NCRs) and Corrective and Preventive Action Requests (CAPAs).
- Assist with investigation and resolution of customer complaints.
- Review, revise, and edit Quality Management System documentation, follow good documentation practices.
- Perform any other quality assurance and regulatory tasks as required.

**What We Are Looking For**
- Post-secondary education, or equivalent experience, in health science, engineering or other related technical discipline.
- 2+ years experience in a regulatory role.
- Strong interpersonal, organizational, problem-solving, and analytical skills.
- Demonstrated writing and communication skills, with the ability to communicate effectively at multiple levels of the organization, as well as regulatory agencies.
- Previous experience in medical devices is an asset.
- Prior start-up environment experience and success in launching new technologies is an asset.

**Benefits & Perks**
- Competitive compensation package
- Group health benefits 100% paid by the employer
- Stock Options
- Generous vacation
- Mental health days
- Training and development opportunities
- Remote and flexible working arrangements
- Transit discount