Regulatory Affairs Specialist

4 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

  • Regulatory Affairs Specialist

    17 hours ago

    Mississauga, Ontario, Canada Myant Inc Full time

    About Myant IncMyant Inc is a cutting-edge technology company that is revolutionizing the way we interact with technology. Our mission is to create a world where technology is seamlessly integrated into our daily lives, making it easier for people to connect with each other and with the world around them.Job Title: Regulatory Affairs Senior SpecialistWe are...

  • Regulatory Affairs Specialist

    13 hours ago

    Mississauga, Ontario, Canada Myant Inc Full time

    About Myant IncMyant Inc is a cutting-edge technology company that is revolutionizing the way we interact with technology. Our mission is to create a world where technology is seamlessly integrated into our daily lives, making it easier for people to connect with each other and with the world around them.Job Title: Regulatory Affairs Senior SpecialistWe are...

  • Regulatory Affairs Specialist

    1 week ago

    Mississauga, Ontario, Canada Myant Inc Full time

    About Myant IncMyant Inc is a cutting-edge technology company that is revolutionizing the way we interact with technology. Our mission is to create a world where technology is seamlessly integrated into our daily lives, making it easier for people to connect with each other and with the world around them.Job Title: Regulatory Affairs Senior SpecialistWe are...

  • Regulatory Affairs Specialist

    7 days ago

    Mississauga, Ontario, Canada Myant Inc Full time

    About Myant IncMyant Inc is a cutting-edge technology company that is revolutionizing the way we interact with technology. Our mission is to create a world where technology is seamlessly integrated into our daily lives, making it easier for people to connect with each other and with the world around them.Job Title: Regulatory Affairs Senior SpecialistWe are...

  • Regulatory Affairs Specialist

    7 days ago

    Mississauga, Ontario, Canada Q&C Full time

    {"title": "Regulatory Affairs Specialist", "content": "Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Q&C. As a key member of our Regulatory Services department, you will play a critical role in maximizing and protecting the commercial interests of our clients.As a Regulatory Affairs Specialist, you will be...

  • Regulatory Affairs Specialist

    7 days ago

    Mississauga, Ontario, Canada Q&C Full time

    {"title": "Regulatory Affairs Specialist", "content": "Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Q&C. As a key member of our Regulatory Services department, you will play a critical role in maximizing and protecting the commercial interests of our clients.As a Regulatory Affairs Specialist, you will be...

  • Regulatory Affairs Specialist

    7 days ago

    Mississauga, Ontario, Canada Myant Full time

    About MyantMyant is a pioneering technology company that is revolutionizing the way we interact with technology. Our mission is to create a world where technology is seamlessly integrated into our daily lives, enhancing our well-being and connectivity. We are a multi-disciplinary team of innovators, engineers, and designers working together to push the...

  • Regulatory Affairs Specialist

    1 week ago

    Mississauga, Ontario, Canada Myant Full time

    About MyantMyant is a pioneering technology company that is revolutionizing the way we interact with technology. Our mission is to create a world where technology is seamlessly integrated into our daily lives, enhancing our well-being and connectivity. We are a multi-disciplinary team of innovators, engineers, and designers working together to push the...

  • Regulatory Affairs Specialist

    2 weeks ago

    Mississauga, Ontario, Canada BD Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at BD. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring compliance with global regulatory requirements for medical devices.Key ResponsibilitiesSupport regulatory efforts to comply with new and existing regulations,...

  • Regulatory Affairs Specialist

    2 weeks ago

    Mississauga, Ontario, Canada BD Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at BD. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring compliance with global regulatory requirements for medical devices.Key ResponsibilitiesSupport regulatory efforts to comply with new and existing regulations,...

  • Regulatory Affairs Specialist

    2 weeks ago

    Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at 837 GlaxoSmithKline Inc. as a Regulatory Affairs Associate. This role will be responsible for developing and implementing regulatory strategies to ensure compliance with Health Canada regulations and guidelines.Key ResponsibilitiesDevelop and implement regulatory...

  • Regulatory Affairs Specialist

    2 weeks ago

    Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at 837 GlaxoSmithKline Inc. as a Regulatory Affairs Associate. This role will be responsible for developing and implementing regulatory strategies to ensure compliance with Health Canada regulations and guidelines.Key ResponsibilitiesDevelop and implement regulatory...

  • Regulatory Affairs Specialist

    4 months ago

    Mississauga, Canada Cardinal Health Full time

    Cardinal Health Canada, with over 1300 employees nationwide, is an essential link in the Canadian healthcare supply chain, providing over 70,000 products to healthcare facilities and medical professionals across the country. Cardinal Health Canada is currently seeking a Regulatory Affairs Specialist to join the Regulatory Affairs and Quality Assurance team...

  • Regulatory Affairs Specialist

    1 week ago

    Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at 837 GlaxoSmithKline Inc. as a Regulatory Affairs Associate. This role will be responsible for developing and implementing regulatory strategies to ensure compliance with Health Canada regulations and guidelines.Key ResponsibilitiesDevelop and implement regulatory...

  • Regulatory Affairs Specialist

    1 week ago

    Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at 837 GlaxoSmithKline Inc. as a Regulatory Affairs Associate. This role will be responsible for developing and implementing regulatory strategies to ensure compliance with Health Canada regulations and guidelines.Key ResponsibilitiesDevelop and implement regulatory...

  • Senior Regulatory Affairs Specialist

    1 month ago

    Mississauga, Ontario, Canada Bayer AG Full time

    At Bayer, we are innovators committed to addressing the world's most pressing challenges, striving for a reality where 'Health for all, Hunger for none' is achievable. Our approach is fueled by energy, curiosity, and unwavering dedication, as we continuously learn from diverse perspectives, expand our thinking, enhance our capabilities, and redefine what is...

  • Regulatory Affairs Specialist

    3 weeks ago

    Mississauga, Canada ct bakery Full time

    _We are seeking a dedicated Regulatory Affairs Specialist - _**Food Industry**_ _to join our team. The Regulatory Affairs Manager will play a crucial role in guiding regulation strategies. This position requires strong regulatory knowledge, strategic thinking, and the ability to collaborate effectively across departments and with regulatory...

  • Regulatory Affairs Specialist

    1 month ago

    Mississauga, Ontario, Canada F. Hoffmann-La Roche Gruppe Full time

    F. Hoffmann-La Roche Gruppe values diversity, equity, and inclusion, reflecting the communities we serve. In the realm of global healthcare, diversity is a crucial element for success. We believe that inclusion is vital for understanding the diverse healthcare needs of individuals. Together, we celebrate uniqueness and share a commitment to outstanding...

  • Regulatory Affairs Specialist

    1 month ago

    Mississauga, Ontario, Canada F. Hoffmann-La Roche Gruppe Full time

    F. Hoffmann-La Roche Gruppe values diversity, equity, and inclusion, reflecting the communities we serve. In the realm of global healthcare, diversity is crucial for success. We believe that inclusion is essential for understanding the diverse healthcare needs of individuals. Together, we celebrate uniqueness and share a commitment to outstanding...

  • Regulatory Affairs Specialist

    8 minutes ago

    Mississauga, Ontario, Canada BD Full time

    Job Description SummaryJob DescriptionWe are the pioneers of innovationBD is a leading global medical technology company that is committed to advancing the world of health. Our purpose is to improve the lives of patients and healthcare professionals around the world. We achieve this by developing innovative medical technologies that make a meaningful...