Medical Device Regulatory jobs

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 driven, compassionate, and laser focused on making a dramatic positive impact with everything we undertake.

When you join API, you are part of a rapidly growing team that is creating collaborative opportunities to commercialize Canadian life sciences discoveries, increasing the amount of commercial research and development in the country, and supporting Alberta as a key pillar in Canada’s life sciences sector.

We are seeking a detail-oriented Coordinator, Compliance to support pharmaceutical manufacturing operations at our Biotechnology Business Development Centre. This role is responsible for creating and managing GMP-compliant technical documentation, ensuring regulatory adherence, and supporting batch record review, audits, and quality processes. The successful candidate will be working cross-functionally with Production, Quality, and Engineering teams and will help maintain inspection readiness and uphold data integrity in a fast-paced, regulated environment, contributing to critical drug development and manufacturing initiatives.

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

Key Responsibilities, include but are not limited to:

Technical Documentation Management:

• Author, revise, and manage SOPs, Batch Manufacturing Records, Work Instructions, and Master Production Records.
• Ensure clarity, accuracy, and compliance with GMP requirements.
• Maintain documents within QMS systems.

Compliance Coordination:

• Ensure adherence to GMP regulations (FDA, Health Canada, EU GMP).
• Ensure ALCOA+ data integrity principles are followed.
• Perform periodic document reviews.

Batch Record Review:

• Review executed batch records for completeness, accuracy, and compliance.
• Identify discrepancies and collaborate with QA and production teams.

Change Control & Deviation Support:

• Support change control processes and documentation updates.
• Assist deviation investigations and CAPA implementation.

Audit & Inspection Readiness:

• Support internal and regulatory audits.
• Maintain documentation in an inspection-ready state.

Training & Collaboration:

• Coordinate SOP training assignments.
• Collaborate cross-functionally with Production, QA, QC, Validation, and Engineering teams.

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

Education

• Bachelor’s or Master’s degree related to pharmaceutical product manufacture.
• An equivalent combination of education and experience will be considered.

Experience

• 1-3 years of experience in cGMP regulated pharmaceutical manufacturing environment.
• Experience in pharmaceutical manufacturing is preferred.
• Strong technical writing skills, independently create SOPs, investigate and write deviations, initiate change controls is preferred.

Personal Competencies

• Ability to take direction.
• Enthusiastic and willing to learn.
• Strong oral and written communication.
• Good interpersonal skills with the ability to interact with people at all levels with sensitivity and tact

Working Conditions:

• Required travel between Edmonton API sites.
• This position requires you to be on site.
• Work is performed in office and cleanroom environments.
• Gowning required for sterile operations.
• May require flexibility to support audits and production schedules.
• Lifting/pushing/pulling up to 25lbs, and direct contact with alcohol/chlorine based disinfectant agents
• Possible exposure to chemicals, machinery, or equipment.

Additional Required Documents to Support Application

• Applications submitted without a resume AND cover letter will not be reviewed.

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.

Retirement Savings: API offers a RRSP Matching Program. Employees may be eligible to participate, with API matching of contributions up to 1–3% of base salary, in accordance with program terms.

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: We understand the importance of taking time off to recharge and maintain a healthy work-life balance. API offers a generous paid time off (PTO) policy that includes vacation days, medical/personal days, and holidays. We encourage our employees to prioritize their well-being and enjoy quality time away from work.

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.

Work From Home: Eligible employees are entitled to 20 Work from Home days, this is subject to job function, company needs, and manager approval.

How to Apply

Interested applicants must submit a resume and cover letter expressing their interest in the position and why they believe they are a strong candidate.

We appreciate all applicants' interest and will only contact those selected for interviews.

If you have any questions about the application process or require accommodations during the hiring process, please contact careers@appliedpharma.ca.

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.

This position will remain open until filled.

Pay: $74,750.00-$97,750.00 per year

Benefits:

• Company events
• Dental care
• Employee assistance program
• Extended health care
• On-site parking
• RRSP match
• Vision care
• Work from home

Work Location: In person