Regulatory Affairs Specialist

Applied Pharmaceutical Innovation (API) brings life-saving research to the real world by helping life science innovators bridge the gap between academic research and commercial product development.

We are seeking an experienced and dedicated Regulatory Affairs Specialist with a minimum of 5 years in regulatory affairs for medical devices, including both hardware and software-based products. In this role, you will be responsible for ensuring compliance with Health Canada and FDA regulations, as well as applicable industry standards. You will play a key role in developing and executing regulatory strategies, obtaining and maintaining approvals, and providing expert regulatory guidance to cross-functional teams, clients, and stakeholders. This position also involves mentoring junior regulatory staff and supporting the growth of interns and co-op students, fostering a collaborative environment to meet the evolving needs of API’s clients and projects.

** Please note this position requires full-time on-site presence.

Key Responsibilities, include but are not limited to:

Client Regulatory Interface and Compliance Management

• Serve as the primary regulatory point of contact for clients in the life sciences Medtech sector, covering both Software as a Medical Device (SaMD) and hardware devices. Foster strong relationships, understand regulatory needs, and provide expert guidance throughout the Health Canada and FDA regulatory processes.
• Collaborate with clients to develop and implement strategic regulatory plans that support successful submissions and approvals for a range of medical devices, including SaMD, digital health technologies, and traditional hardware devices.
• Provide expert interpretation of global regulatory requirements, primarily for Health Canada and FDA, ensuring clients’ compliance with best practices and guidelines for both software and hardware-based medical devices.
• Conduct regulatory assessments and gap analyses for clients' products, identifying potential risks, challenges, and opportunities in both software and hardware development, and offering strategic recommendations to enhance regulatory readiness.
• Prepare and review documentation, including device specifications, software development processes, manufacturing details, stability data, and quality control strategies, to ensure compliance with regulatory standards for both SaMD and hardware devices.
• Lead the preparation and submission of regulatory filings, such as Class II-IV Medical Device License applications, investigational testing authorizations, amendments, and post-approval submissions with a focus on both software and hardware compliance.
• Conduct thorough reviews of product labeling, advertising materials, and promotional activities to ensure they align with regulatory requirements for all types of medical devices.

Regulatory Submission and Document Management

• Prepare high-quality regulatory submissions in accordance with Health Canada and FDA standards for both software and hardware devices. This includes:
• Evaluating available data, including clinical, pre-clinical, software performance, and labeling information.
• Preparing comprehensive submission modules, such as Device Master File and summaries, tailored to both software and hardware devices to meet Health Canada and FDA requirements.
• Drafting responses to clarification requests in alignment with regulatory authorities’ deadlines.
• Manage the entire document lifecycle of an eCTD submission for a diverse range of devices, including SaMD and hardware.
• Lead preparations for regulatory meetings with applicable authorities, ensuring readiness for discussions on both software and hardware device-specific issues.
• Oversee regulatory activities related to licensing and maintenance of medical devices marketed in Canada, the U.S., and minimally in Europe, with comprehensive expertise across SaMD and hardware-based devices.
• Coordinate with stakeholders and clients during dossier preparation, submission, and throughout Health Canada/FDA review processes.

Internal Regulatory Affairs Support

• Act as the qualified person for regulatory affairs matters for medical devices, addressing inquiries raised by internal stakeholders and corporate partners.
• Collaborate with internal teams to develop and update Standard Operating Procedures (SOPs) in alignment with Health Canada and FDA requirements for medical devices.
• Work closely with cross-functional teams to ensure compliance with Health Canada and FDA regulatory standards throughout the product lifecycle.
• Mentor interns, co-op students, and contribute to the development of junior regulatory affairs staff, fostering a culture of growth and knowledge-sharing within the team.
• Oversee and manage an Associate, Regulatory Affairs providing guidance, performance feedback, and support to ensure effective execution of regulatory tasks and professional development.

Regulatory Strategy and Knowledge Leadership

• Stay current with regulatory trends, changes, and evolving requirements in Canada and the U.S., and proactively communicate updates to clients, guiding them on necessary adaptations for compliance.
• Communicate regulatory requirements and updates to internal stakeholders, ensuring awareness and adherence to Health Canada and FDA regulations.
• Engage with regulatory authorities, industry associations, and external consultants to stay updated on best practices for Canadian and U.S. regulatory compliance.
• Represent the company in meetings, audits, inspections, and other regulatory interactions specific to Health Canada and FDA compliance.
• Develop and implement comprehensive regulatory training programs within the organization to ensure compliance with Canadian and U.S. regulatory standards.

Qualifications - (Education, Certification, Degree, Skills, Knowledge, etc.)

Education

• Minimum of a Bachelor's degree in a relevant field; Master’s degree preferred.
• Regulatory Affairs Certification (RAC)

Experience

• Minimum of 5 years of experience in regulatory affairs within the medtech sector, with strong expertise in the regulatory pathways for both Software as a Medical Device (SaMD) and hardware devices.
• Proven experience in regulatory submissions to Health Canada (MDL, ITA) and the FDA (510(k), PMA), with a strong track record of collaborating effectively with these agencies to gain approvals and ensure ongoing compliance for both software and hardware-based medical products.
• Strong knowledge of Health Canada’s Medical Device Regulations (MDR) and FDA 510(k)/PMA pathways, as well as relevant ISO standards (e.g., ISO 13485). Understanding of device development processes, including design controls, clinical evaluations, and post-market surveillance for compliance with Health Canada and FDA standards.
• Experience working with biotech startups and early-stage companies, particularly in medtech and medical device development.

Personal Competencies

• Proficiency in regulatory systems, databases, and software related to medical device compliance.
• Strong analytical and problem-solving skills, with the ability to make strategic decisions in complex regulatory environments.
• Excellent communication, negotiation, and presentation skills, with the ability to build relationships with clients, regulatory agencies, and internal stakeholders.
• Ability to work independently and excel in a dynamic, fast-paced environment.

Working Conditions

• Required travel between Edmonton API sites.

Additional Required Documents to Support Application

• Applications submitted without a resume AND cover letter will not be reviewed.
• Regulatory Affairs Certification (RAC)

Perks and Benefits at API

Comprehensive Health Coverage: At API, we prioritize the well-being of our employees. We offer a comprehensive health coverage plan. Our premiums are 100% covered, ensuring that you and your dependents receive the necessary healthcare support.

Payment in Lieu of Pension: API provides an additional 15% of your annual base salary, as an alternative to traditional pension benefits.

Professional Development Opportunities: We foster a culture of continuous learning and growth. API provides access to various professional development opportunities, including training programs, workshops, conferences, and certifications. We encourage employees to enhance their skills, broaden their knowledge, and stay updated with the latest advancements in the life sciences industry.

Collaborative and Inclusive Environment: At API, we believe in the power of collaboration and diversity. We foster an inclusive work environment that values and respects individuals from all backgrounds. We promote teamwork, open communication, and a supportive atmosphere where everyone's contributions are valued.

Generous Paid Time Off: API offers a generous paid time off (PTO) policy that includes vacation days, medical/personal days, and holidays.

Green Transit Allowance: Employees based out of an office are eligible to enroll in our green transit program, which promotes the use of environmentally friendly modes of transportation. By participating in the program, you commit to making green transit your primary mode of transportation for at least 75% of your commute to and from work. Green transit includes walking, biking, carpooling, and public transportation.

How to Apply

Interested applicants must submit a resume and cover letter.

Our team, clients, and stakeholders come from a variety of backgrounds. In recruiting for our team, we welcome the unique contributions that all people bring to the workplace in terms of varied lived experiences, education, culture, gender, race, sexual orientation, religious or ethnic background, neurodiversity, and cognitive and physical ability.

Before employment, successful candidates will be required to meet the requirements of a pre-employment screening, which includes background reference checks, educational credential verification, and criminal reference checks.

Application Deadline: November 27, 2024