Regulatory Affairs Manager

3 months ago

Mississauga, Canada Trexo Robotics Full time

**About us**:
Trexo Robotics (Y Combinator Company) is enabling mobility by building powered wearable robots. Our first product is a robot for children with movement disorders such as Cerebral Palsy, and it allows kids to walk, in many cases, for the first time in their lives. The device is currently being used by hundreds of families and the best hospitals across North America.

We are constantly working towards building mobility solutions for all. At Trexo Robotics, you will find a flat organization where you can work with highly optimistic, low ego, and exceptionally talented individuals who look forward to solving hard problems.

**About the job**:
We are a fast-growing startup with an ever-increasing backlog of orders and are looking for a highly motivated and experienced Regulatory Affairs (RA) Manager to lead regulatory projects. As part of the small team, you will be a strategic partner to company co-founders, and assist in navigating the complex regulatory landscape to ensure that Trexo robotics meet regulatory requirements within the medical device and robotics industry.

Trexo's work doesn’t stop with children. We are constantly working towards building mobility solutions for all. At Trexo Robotics, you will find a flat organization where you can work with highly optimistic, low ego, and exceptionally passionate and talented individuals who look forward to solving hard problems.

**About you**:
You want to work in a small team solving a big problem. You are excited by the prospect of revolutionizing multiple industries. You can juggle many tasks simultaneously. You are detail-oriented and love asking why many times till you understand something from first principles.

You have a successful track record of leading complex regulatory projects for a small to midsize company and appreciate the difference between quality requirements for different sizes of companies.

**What you'll do**:

- Develop and implement regulatory strategies to ensure compliance with applicable regulations and standards, including ISO 13485, FDA CFR Part 820.
- Work closely with the Quality Assurance Lead to ensure that the required documentation and quality management systems are up to date with recent changes in regulations.
- Act as the main point of and build relationship with various regulatory bodies, including Health Canada, the FDA, or the EMA.
- Lead preparation of regulatory filings such as IDE, 510(k), CE Mark, and others.
- Oversee post-market surveillance activities, including adverse event reporting, complaint handling, and field actions.
- Provide ongoing support to project teams for regulatory issues and questions.
- Secure necessary Institutional Review Board approvals to maintain ethical standards for user testing and clinical trials.
- Conduct internal audits and work with 3rd party auditors.

**Required Skills**:

- 4+ years of demonstrated success in the regulatory role for a medical device company with a product on the market.
- Very good understanding of medical device regulations in Canada and USA for Class I-II device.
- Proficient understanding of quality management systems, regulatory requirements (e.g., ISO 13485, ISO 14971, IEC 62304, FDA CFR Part 820), and quality tools/methodologies (e.g., CAPA, risk management, root cause analysis).
- Experience in interacting with representatives from the FDA or other regulatory agencies.
- Good understanding of QMS for an early-stage product and new product development from ideation specification, through market launch and revenue generation, and post-launch maintenance.
- Experience in managing people, internal teams, and/or contractor partners.
- Strong project management skills.
- Strong analytical skills with attention to detail and the ability to interpret data and trends.
- Excellent communication and collaboration skills to work effectively across multidisciplinary teams.
- Proven ability to prioritize tasks, meet deadlines, and adapt to changing priorities in a fast-paced environment.

**Nice to Have**:

- Applied experience in business process techniques, including but not limited to LEAN and SIX SIGMA methodologies, to improve existing workflows.
- Good understanding of medical device regulations globally, e.g. European Union, or Australia.

**Compensation and Benefits**:

- Competitive pay and employee stock options.
- Unlimited Vacation policy.
- Group benefits plan (in 100% covered by the company).
- Snacks in the office.
- Dog friendly office.

  • Regulatory Affairs Manager

    4 days ago

    Mississauga, Ontario, Canada Alectra Utilities Inc. Full time

    Job SummaryAlectra Utilities Inc. is seeking a highly skilled Regulatory Affairs Manager to lead the Regulatory Affairs department and ensure compliance with industry regulations. The successful candidate will provide leadership and support to the team, managing resources and processes to ensure timely and accurate reporting of regulatory requirements.Key...

  • Regulatory Affairs Manager

    5 days ago

    Mississauga, Ontario, Canada Alectra Utilities Inc. Full time

    Job SummaryAlectra Utilities Inc. is seeking a highly skilled Regulatory Affairs Manager to lead the Regulatory Affairs department and ensure compliance with industry regulations. The successful candidate will provide leadership and support to the team, managing resources and processes to ensure timely and accurate reporting of regulatory requirements.Key...

  • Regulatory Affairs Manager

    2 weeks ago

    Mississauga, Canada Furlani Foods Full time

    The Regulatory Affairs Manager role is responsible for developing and enforcing compliance of products to North American food regulations. This position is responsible to providing regulatory leadership to educate stakeholders of the regulatory landscape, ensuring products compile with requirements and develop systems to ensure proper documentation.KEY...

  • Regulatory Affairs Manager

    2 weeks ago

    Mississauga, Canada Furlani Foods Full time

    The Regulatory Affairs Manager role is responsible for developing and enforcing compliance of products to North American food regulations. This position is responsible to providing regulatory leadership to educate stakeholders of the regulatory landscape, ensuring products compile with requirements and develop systems to ensure proper documentation.KEY...

  • Regulatory Affairs Manager

    2 weeks ago

    Mississauga, Canada Furlani Foods Full time

    The Regulatory Affairs Manager role is responsible for developing and enforcing compliance of products to North American food regulations. This position is responsible to providing regulatory leadership to educate stakeholders of the regulatory landscape, ensuring products compile with requirements and develop systems to ensure proper documentation.KEY...

  • Regulatory Affairs Manager

    4 days ago

    Mississauga, Ontario, Canada Alectra Utilities Inc. Full time

    Job SummaryAlectra Utilities Inc. is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for providing leadership and support to ensure compliance with industry regulations and standards.Key ResponsibilitiesLead and manage the timely and accurate reporting of all...

  • Regulatory Affairs Manager

    6 days ago

    Mississauga, Ontario, Canada Alectra Utilities Inc. Full time

    Job SummaryAlectra Utilities Inc. is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for providing leadership and support to ensure compliance with industry regulations and standards.Key ResponsibilitiesLead and manage the timely and accurate reporting of all...

  • Regulatory Affairs Manager

    2 weeks ago

    Mississauga, Canada Brunel Full time

    Introduction We are seeking a Regulatory Affairs Manager working in a full-time permanent position with our client. Reporting to the Director of Regulatory Affairs, the Manager responsible for developing and executing regulatory strategies to achieve rapid product approvals with optimal labeling. M

  • Regulatory Affairs Manager

    3 months ago

    Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal...

  • Regulatory Affairs Specialist

    3 weeks 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 Associate

    3 months ago

    Mississauga, Canada Bayer Full time

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...

  • Regulatory Affairs Specialist

    3 weeks 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

    4 days 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

    4 days 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 Manager

    3 weeks ago

    Mississauga, Canada Furlani Foods Full time

    PURPOSE STATEMENT: The Regulatory Affairs Manager role is responsible for developing and enforcing compliance of products to North American food regulations. This position is responsible to providing regulatory leadership to educate stakeholders of the regulatory landscape, ensuring products compile with requirements and develop systems to ensure proper...

  • Regulatory Affairs Manager

    3 weeks ago

    Mississauga, Canada Furlani Foods Full time

    PURPOSE STATEMENT: The Regulatory Affairs Manager role is responsible for developing and enforcing compliance of products to North American food regulations. This position is responsible to providing regulatory leadership to educate stakeholders of the regulatory landscape, ensuring products compile with requirements and develop systems to ensure proper...

  • Regulatory Affairs Manager

    3 weeks ago

    Mississauga, Canada Furlani Foods Full time

    PURPOSE STATEMENT: The Regulatory Affairs Manager role is responsible for developing and enforcing compliance of products to North American food regulations. This position is responsible to providing regulatory leadership to educate stakeholders of the regulatory landscape, ensuring products compile with requirements and develop systems to ensure proper...

  • Regulatory Affairs Specialist

    3 weeks ago

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

    Company OverviewF. Hoffmann-La Roche Gruppe is committed to fostering diversity, equity, and inclusion, reflecting the communities we serve. We recognize that diversity is vital for success in the global healthcare landscape. Inclusion is essential for understanding the diverse healthcare needs of individuals. At Roche, every voice is valued, and we share a...

  • Regulatory Affairs Manager

    2 weeks ago

    Mississauga, Canada Brunel Full time

    We are seeking a Regulatory Affairs Manager working in a full-time permanent position with our client.Reporting to the Director of Regulatory Affairs, the Manager is responsible for developing and executing regulatory strategies to achieve rapid product approvals with optimal labeling. Managing a portfolio of oncology products, this role ensures compliance...

  • Regulatory Affairs Manager

    3 weeks ago

    Mississauga, Canada Brunel Full time

    We are seeking a Regulatory Affairs Manager working in a full-time permanent position with our client.Reporting to the Director of Regulatory Affairs, the Manager is responsible for developing and executing regulatory strategies to achieve rapid product approvals with optimal labeling. Managing a portfolio of oncology products, this role ensures compliance...