Director of Quality and Regulatory Affairs

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COMPANY INFORMATION

Founded in 2019 and based in Montreal, MY01 envisions a world where every disease is quantifiable, enabling precise, personalized care for all patients. Specializing in managing limb ischemia and compartment syndrome, our tools provide proactive monitoring and actionable insights through a connected care team that benefits patients, providers, and payers. MY01 is commercial in the USA, Europe and Canada, setting new standards in healthcare.

INTRODUCTION TO ROLE

MY01 Inc. is seeking a highly skilled and experienced Director of Quality and Regulatory Affairs to lead our regulatory and quality initiatives. The successful candidate will play a pivotal role in ensuring compliance with regulatory requirements and maintaining the highest quality standards across MY01 Inc. The ideal candidate will demonstrate meticulous attention to detail, adaptability to new environments and challenges, and a commitment to our core values of trust, responsibility, compassion, curiosity, and accountability.

In this role, you will gain valuable experience in a fast-moving, collaborative, and high-performing startup environment while leading a team of highly skilled and knowledgeable individuals. The Director of Quality and Regulatory Affairs will report directly to the Chief Operating Officer and will work a total of 40 hours per week.

If you are a motivated and experienced regulatory affairs and quality management professional looking to join a dynamic team at the forefront of medical innovation, we encourage you to apply for the Director of Quality and Regulatory Affairs position at MY01 Inc.

Responsibilities

• Leads and manages the Quality Assurance, Quality Control and Regulatory Affairs teams.
• Leads efforts in establishing and maintaining a robust ISO 13485 certified QMS and acts as the Management Representative.
• Oversees compliance of MY01 Inc. to regulations and standards from relevant jurisdictions, including US (FDA), Canada (Health Canada) and Europe (MDD / MDR).
• Fosters a company-wide culture of quality and regulatory compliance by promoting awareness and adherence to requirements.
• Serves as the primary liaison with regulatory agencies, ensuring timely communication and collaboration.
• Develops and implements regulatory strategies to obtain and maintain regulatory approvals for MY01 Inc.'s products, including FDA submissions and international regulatory submissions.
• Provides regulatory guidance and support to cross-functional teams throughout the product development lifecycle, including R&D, manufacturing, and clinical affairs.
• Oversees the preparation and submission of regulatory documents, including 510(k) submissions, IDE applications, and regulatory correspondence.
• Actively participates in QMS activities, including but not limited to management reviews, design control, risk management, supplier management, quality control and production, medical device file maintenance, nonconformances, corrective and preventive actions (CAPA), post-market surveillance including complaint handling and adverse event reporting, analysis of data, training, internal and supplier audits, change control, product releases, etc.
• Collaborates with cross-functional teams to ensure that quality and regulatory requirements are integrated into company activities from product conception to commercialization.
• Stays updated on regulatory developments and industry trends (cGMP) to proactively ensure the company remains at the forefront of industry standards and regulatory compliance.

Qualifications

• 8+ years of experience in the medical device / pharmaceutical field or other regulated industries; with at least 4 years of managerial experience.
• Bachelor's degree in a relevant scientific or technical field; advanced degree is preferred.
• Experience in establishing and maintaining an ISO 13485 QMS; ISO Lead Auditor certification is strongly preferred.
• Strong knowledge of FDA, Health Canada and European regulatory requirements for medical devices; RAC - Devices is preferred.
• Proven track record of successful regulatory submissions and approvals, including 510(k) submissions, Health Canada submissions and Technical Files for CE Mark.
• Experience with SaMD regulations and cybersecurity is a plus.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders.
• Strong leadership skills with the ability to lead and mentor a team.
• Detail-oriented with excellent problem-solving and analytical abilities.
• Ability to thrive in a fast-paced, dynamic environment and manage multiple priorities effectively.

Applicants are encouraged to apply even if they don’t meet ALL the criteria listed above.

BENEFITS & PERKS

At MY01, we prioritize the well-being and satisfaction of our team members. Here are some of the benefits we offer:

• Prime Location: Our office is conveniently situated in downtown Montreal, right beside the Place Des Arts metro station.
• Comprehensive Benefits: All permanent employees enjoy access to our Group Benefits Plan with Sun Life, along with an annual Health and Wellness Allowance.
• Flexible Work Environment: We embrace a hybrid work model, allowing employees to spend 50% of their work hours in the office each month, with flexible scheduling. Additionally, our International Remote Work Policy permits employees to work abroad for several weeks per year.
• Generous Time Off: In addition to a minimum of three weeks of vacation annually, we observe a holiday office closure at the end of each year to encourage everyone to disconnect and recharge for the upcoming year.
• Ownership Opportunity: Employees have the chance to share in our success through participation in our Employee Stock Option Plan.
• Further Education: MY01 offers its employees the opportunity to expand their knowledge and to invest in their professional development through our Further Education support policy.
• Office Perks: Enjoy complimentary smoothies, coffees, bagels, and other snacks at our office. Take advantage of our designated break room, equipped with a foosball table, seating area, and small library.
• Fully Equipped Kitchen: Our kitchen is stocked and ready for you to prepare your breakfast or lunch. Plus, we have a beer tap installed for those well-deserved after-work gatherings.
• Team Events: We foster a sense of community through regular 5@7 social gatherings and quarterly team bonding and wellness events. Don't miss our annual retreat in the scenic Laurentians.

If you are looking to continue your career with a supportive team, gain valuable work experience and have what it takes to join MY01 Inc., please send us your resume, we would love to hear from you

MY01 Inc. is an Equal Opportunity and Affirmative Action employer. We are committed to creating a work environment based on mutual respect, hard work and inclusion without bias or discrimination. Our team is made up of people from all backgrounds and walks of life, and each member is valued for what they know and what they can contribute. As a collective we are continuously learning and encourage each other to push our boundaries and make mistakes we can all learn from. Those who do so will get an opportunity to grow with us and share in our success.