Regulatory Affairs Manager

**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.