Regulatory Affairs Specialist

2 months ago

Mississauga, Canada Profound Medical Full time

Our mission is to Profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives. Changing the standard of care is part of our fabric. We are a group of energetic, problem-solvers focused on innovation, and looking to change the world. We are changing the paradigm for treating diseases such as prostate cancer by using real-time MR Imaging, thermal ultrasound and close-loop temperature feedback control, to gently ablate the diseased tissue with mínimal side effects.

If you share our values and want to work in a collaborative results focused culture and want to make a Profound impact in healthcare and your career, here is your chance.

**General Accountability**:
Support regulatory compliance throughout the organization by performing the required activities necessary for the licensing and approvals of devices both domestically and internationally.

Help refine and maintain systems that support regulatory compliance and for retrieving and organizing regulatory related information. Accountability includes directly communicating with regulatory authorities worldwide until the product is successfully registered.

**Duties and Responsibilities**:

- Contribute to a positive, high-performance work culture.
- Provide guidance to internal stakeholders to maintain compliance with domestic and international device regulations.
- Ensure that all (investigational and marketing submissions) domestic and international regulatory submissions are prepared and submitted accurately, completely, and in a timely manner to meet business objectives. Follow-up, track and assemble regulatory responses to regulatory agencies in a timely manner and or as required.
- Organize and maintain regulatory files. Assure that appropriate maintenance of registrations occurs including renewals, establishment license, device listings, site registrations, supplements for changes, annual reports etc.
- Provide regulatory guidance to internal stakeholders during the import and export of the devices.
- Participate in the review of processes and or product design changes, labeling, claims, complaints, etc., to determine the need for any regulatory activities and to ensure compliance with regulatory requirements.
- Maintain product UDI listings in country-specific databases.
- Support external regulatory agency audits, providing regulatory input to minimize the potential for findings of non-compliance.
- Participate in post-market surveillance activities for marketed products.
- Lead the preparation and execution of Field Action activities.
- Assist in fulfilling requirements of the Person Responsible for Regulatory Compliance under the EU MDR 2017/745.
- Maintain QMS procedures related to regulatory responsibilities, product licensing, and regulatory reporting.
- Assist with other duties, as assigned.

**Education and Certification**:

- Bachelor’s degree or country equivalent in Engineering, Science, related scientific discipline, or equivalent. Higher degree will be an advantage
- RAPS certification, preferred

**Key Attributes (experience, skills and technical knowledge)**:

- Minimum of 2 years of regulatory affairs and or quality assurance experience within a medical device organization
- Knowledge of the product development life cycle
- Clear/concise regulatory writing skills
- Prior experience with independently handling product approvals
- Detail-oriented with the ability to effectively and efficiently get work done within anticipated timelines
- Demonstrate both creative and critical thinking skills
- Documented training on current medical device standards and regulations is an asset (e.g. MDSAP, EU MDR, ISO 13485, etc.)
- Combined knowledge of science/engineering and life science industry regulations, guidelines, and standards
- Excellent written and verbal communication skills with the ability to listen, articulate and advocate
- Proactive, high performance, result-oriented and manage projects with ethical integrity
- Ability to identify compliance risks and escalate when necessary

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