Regulatory Affairs Specialist

About us

We are professional, agile, and innovative.

Our work environment includes:

• Modern office setting
• Food provided
• Modern office setting
• Growth opportunities
• Wellness programs
• Work-from-home days

Job Summary:

We are seeking a highly skilled and motivated Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with all applicable regulations and standards within the industry. Your attention to detail and strong analytical skills will be crucial in navigating complex regulatory requirements. This is an excellent opportunity for someone who is passionate about Regulatory Affairs and wants to make a significant impact in the field.

Our first product, Momentum Spine, is FDA Cleared as a SaMD (Class 2) and holds an active MDEL in Canada (Class 1). Our eQMS is implemented. We are looking to apply for EU MDR Class 2a approval shortly.

Duties:

- Develop and implement regulatory strategies to ensure compliance with local, national, and international regulations

- Review and interpret regulatory guidelines and requirements to assess their impact on product development and commercialization

- Prepare and submit regulatory submissions, including pre-market notifications, product registrations, and periodic reports

- Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle

- Conduct regulatory assessments of new products or changes to existing products

- Stay up-to-date with changes in regulations and communicate relevant updates to internal stakeholders

- Provide guidance and support during regulatory inspections or audits

- Maintain accurate documentation of all regulatory activities

Experience:

- Bachelor's or master's degree in a related field (e.g., life sciences, pharmacy, chemistry)

- Proven experience working in Regulatory Affairs within the industry

- Strong knowledge of relevant regulations and standards (e.g., FDA, ISO)

- Experience in supervising or leading projects is preferred

- Excellent project management skills with the ability to prioritize tasks effectively

- Strong leadership abilities with the capability to influence cross-functional teams

- EU MDR knowledge and experience is a plus

- Ability to adapt quickly to changing regulations and industry trends

We offer competitive compensation packages along with benefits such as medical and dental insurance, and professional development opportunities. If you are looking for a challenging role where you can contribute to the success of our organization while further developing your skills in Regulatory Affairs, we encourage you to apply.

Job Types: Full-time, Part-time, Permanent, Freelance

Salary: $40.00-$80.00 per hour

Expected hours: 20 – 40 per week

Benefits:

• Dental care
• Extended health care
• Flexible schedule
• Paid time off
• Stock options
• Work from home

Flexible Language Requirement:

• French not required

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay
• Overtime pay

Education:

• Bachelor's Degree (preferred)

Work Location: Hybrid remote in Montréal, QC H3K 0A8