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Regulatory Affairs Specialist

MDA Edge

Role overview

Qualifications

  • Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biomedical Engineering, or a related field
  • 3+ years of experience in regulatory affairs within the pharmaceutical, medical device, biotechnology, cosmetics, or natural health products industry
  • Strong knowledge of Health Canada regulations, including experience with regulatory submissions, product licensing, and compliance requirements
  • Excellent organizational, communication, and problem-solving skills

Responsibilities

  • Prepare, submit, and manage regulatory submissions to Health Canada and other relevant authorities
  • Ensure compliance with applicable Canadian laws, regulations, and guidelines
  • Maintain up-to-date knowledge of regulatory requirements and communicate changes to internal teams
  • Liaise with Health Canada and other regulatory agencies for product registrations, licensing, and renewals

Key facts

Hard skills

Health Laws Good Clinical Practices (GCP) Project Management

Other skills

  • Organizational Skills
  • Verbal Communication Skills
  • Motivational Skills
  • Microsoft Office
  • Time Management

About the company

MDA Edge logo

MDA Edge

Business Consulting & Services

Our objective is to establish an exceptional ecosystem by connecting individuals, technology, and prospects through the application of human intelligence.MDA Edge is a process-oriented company and our expertise lies in providing comprehensive Workforce Solutions, specifically focusing on Contingent Staffing, Bulk/Project Staffing, RPO/KPO/BPO, and Direct Hire services. We cater to a wide range of industries, including Infrastructure Consulting, Engineering Consulting, IT Consulting, Healthcare, Life Sciences, Pharmaceutical Consulting, Consumer Goods, Education, Transportation & Logistics, Media & Entertainment, Telecom, BFSI, Manufacturing, Utilities & Energies, and Corporate Recruitment. Moreover, we have developed a dedicated focus on Government Consulting.Our company prides itself on a meticulous approach, ensuring that we meet your specific needs. We have established a robust network of highly skilled professionals who are readily available to fulfill your requirements. With a strong commitment to excellence, we consistently deliver exceptional results for clients in India, Denmark, France, Germany, Ireland, Japan, Spain, Thailand, the USA, Canada and Mexico, with ongoing expansion efforts to serve more new regions in the near future.We consistently uphold the highest standards of quality by providing resources, time, and materials to design, implement, and support efficient operations for organizations. Our track record of measurable accomplishments demonstrates our commitment to cultivating a balanced work and societal ecosystem.Our continuous growth, successful customer engagements, and strong customer retention exemplify our achievements. Furthermore, our passion lies in streamlining complex business processes through the application of suitable technology, which has been integral to our success.We extend an invitation to join our dynamic workplace, offering rapid growth opportunities, excellent employee benefits, and a positive work-life balance.

Company details

Company typeScaleup
IndustryBusiness Consulting & Services
Company size201 - 500

Links

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Job description

Job Summary: We are seeking a detail-oriented and experienced Regulatory Affairs Specialist to join our team in Canada. The successful candidate will be responsible for ensuring compliance with Canadian regulatory requirements for our products, working closely with internal teams and regulatory agencies to facilitate approvals and maintain compliance.
Key Responsibilities:
  • Prepare, submit, and manage regulatory submissions to Health Canada and other relevant authorities.
  • Ensure compliance with applicable Canadian laws, regulations, and guidelines, including the Food and Drugs Act, Medical Devices Regulations, Natural Health Products Regulations, and other industry-specific requirements.
  • Maintain up-to-date knowledge of regulatory requirements and communicate any changes to internal teams.
  • Assist in the development, review, and approval of labeling, advertising, and promotional materials to ensure regulatory compliance.
  • Liaise with Health Canada and other regulatory agencies as necessary for product registrations, licensing, and renewals.
  • Support quality assurance and compliance initiatives, including audits, inspections, and risk assessments.
  • Prepare and maintain regulatory documentation, including technical files, regulatory dossiers, and product safety reports.
  • Collaborate with cross-functional teams, including R&D, manufacturing, and marketing, to ensure regulatory requirements are met throughout product development and commercialization.
  • Provide training and guidance to internal teams on regulatory affairs processes and requirements.
Qualifications & Experience:
  • Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biomedical Engineering, or a related field.
  • 3+ years of experience in regulatory affairs within the pharmaceutical, medical device, biotechnology, cosmetics, or natural health products industry.
  • Strong knowledge of Health Canada regulations, including experience with regulatory submissions, product licensing, and compliance requirements.
  • Familiarity with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and ISO standards is an asset.
  • Excellent organizational, communication, and problem-solving skills.
  • Ability to manage multiple projects and meet deadlines in a fast-paced environment.
  • Proficiency in Microsoft Office Suite and regulatory submission software.
Preferred Qualifications:
  • Regulatory Affairs Certification (RAC) is a plus.
  • Experience with international regulatory affairs (e.g., FDA, EMA) is beneficial.
  • Bilingual (English/French) is an asset.

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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