Regulatory Affairs Strategist

2 weeks ago


Calgary, Alberta, Canada Fluid Biomed Inc. Full time
Job Overview

We are seeking a highly skilled Regulatory Affairs Specialist to join our technical team at Fluid Biomed Inc., an innovative medical device startup focused on developing novel implantable devices.

Estimated Salary Range:

$80,000 - $110,000 per year based on experience and qualifications.

Key Responsibilities:
  • Develop regulatory strategies for Class III implantable devices, ensuring compliance with applicable regulations and standards.
  • Prepare and submit FDA pre-submissions, Investigational Device Exemptions (IDE), Pivotal Study applications, and Premarket Approval (PMA) submissions for Class III implantable devices.
  • Write, analyze, and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents.
  • Review and interpret regulatory guidelines, ensuring all submissions meet regulatory requirements.
  • Update and maintain authorizations (e.g., IDEs, 510(k)s, Canadian licenses, CE dossiers) and manage renewals, device listings, and site registrations.
Required Skills and Qualifications:
  • Minimum of Bachelor's degree in Biological Sciences, Biochemistry, Chemistry, Toxicology, Pharmacy, Medicine, Engineering, Pharmacology or related field.
  • Minimum 3 years in regulatory affairs and/or quality assurance within a medical device organization.
  • Strong understanding of FDA regulations and guidance documents.
  • Proven experience in preparing IDE, clinical trial, and PMA submissions.
  • Excellent organizational skills and attention to detail.
  • Ability to work independently and as part of a collaborative team.
  • Strong communication and interpersonal skills.
Benefits:
  • Competitive salary range.
  • Ongoing training and professional development opportunities.
  • Collaborative and dynamic work environment.


  • Calgary, Alberta, Canada Fluid Biomed Inc. Full time

    At Fluid Biomed Inc., we are seeking a highly skilled Regulatory Affairs Strategist to support the development and commercialization of our innovative neurovascular stent. This is an exciting opportunity to join our technical team and play a crucial role in shaping the future of medical device regulation.About the RoleWe are looking for a seasoned...


  • Calgary, Alberta, Canada Brainhunter Systems Ltd Full time

    Job OverviewWe are seeking an experienced Regulatory Compliance Strategist to join our team at Brainhunter Systems Ltd. This role will play a critical part in ensuring our company maintains compliance with regulatory requirements.


  • Calgary, Alberta, Canada Fluid Biomed Inc. Full time

    About the RoleFluid Biomed Inc. is seeking a highly skilled Regulatory Affairs Specialist to support the development and commercialization of novel implantable medical devices.Job DescriptionThis full-time opportunity involves working closely with the technical team to prepare and submit FDA pre-submissions, Investigational Device Exemptions (IDE), Pivotal...


  • Calgary, Alberta, Canada Government of Alberta Full time

    The Government of Alberta invites applications for the role of Director, Regulatory Affairs. This position is responsible for driving key initiatives in advancing advocacy and development of regulatory strategy and policies around market access for Alberta's oil and gas.As a member of the Market Access Branch, you will report to the Executive Director and be...


  • Calgary, Alberta, Canada Fluid Biomed Inc. Full time

    **Job Summary**We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Fluid Biomed Inc. This is a full-time opportunity to contribute to the development and commercialization of novel implantable medical devices.About UsFluid Biomed Inc. is an innovative medical device startup focused on developing cutting-edge neurovascular stents...


  • Calgary, Alberta, Canada Artech LLC Full time

    Role OverviewThe Enterprise Risk and Compliance Strategist will lead the Risk & Compliance team in implementing SAP GRC and security strategies to ensure regulatory compliance.


  • Calgary, Alberta, Canada Alberta Electric System Operator Full time

    Compliance Monitoring and Regulatory AffairsWe are seeking a Senior Analyst, External Compliance and Regulatory Affairs to join our team at the Alberta Electric System Operator. As a senior member, you will be responsible for monitoring and analyzing the compliance of market participants with ISO rules and certain Ancillary Service commitments.Key...


  • Calgary, Alberta, Canada PanAccess Innovations Inc. Full time

    About the RoleWe are seeking a highly skilled Chief Financial Strategist to join our team at PanAccess Innovations Inc.Job SummaryThe Chief Financial Strategist will be responsible for coordinating the organization's financial operations and budget activities to optimize financial performance. This role requires identifying and investigating compliance...


  • Calgary, Alberta, Canada ExecThread Full time

    The ExecThread team is seeking a seasoned Senior Corporate Legal Strategist to spearhead their legal operations. This pivotal role involves driving the company's legal strategy, ensuring regulatory compliance, and safeguarding business interests.Key Responsibilities:Contract Management: Develop and review various contracts to ensure alignment with the...

  • Compliance Director

    2 weeks ago


    Calgary, Alberta, Canada HUB International Full time

    At HUB International, we are seeking a seasoned Compliance Director to lead our regulatory affairs across Canada. As a key member of our team, you will play a vital role in ensuring our organization operates within the boundaries of regulatory requirements and industry standards.About the Role:This position requires a deep understanding of financial...


  • Calgary, Alberta, Canada Intricate Full time

    About IntricateIntricate is a leading provider of regulatory solutions to the oil and gas industry. Our comprehensive approach seamlessly integrates consulting, innovative technology, and specialized field services tailored to address the specific needs of our clients.Job SummaryWe are seeking an Environmental Emissions Strategist to join our team in...


  • Calgary, Alberta, Canada Citi Full time

    The Commercial Banking Strategist plays a pivotal role in driving business growth by cultivating strong relationships with clients. This highly strategic professional is responsible for identifying and pursuing new business opportunities aligned with Citi's value proposition.Key responsibilities include actively calling on clients in partnership with...


  • Calgary, Alberta, Canada Trace Associates Inc. Full time

    About UsAt Trace Associates Inc., we are dedicated to empowering our employees to achieve a great life. Our company purpose is built on the foundation of putting people first, trusting them to take care of our business, and giving them the freedom to succeed.Job DescriptionWe are seeking an experienced Senior Financial Strategist to join our team in a key...


  • Calgary, Alberta, Canada Calgary Fetal Alcohol Network Full time

    The Calgary Fetal Alcohol Network is seeking a highly skilled and compassionate Disability Support Strategist to join our team. This rewarding role plays a vital part in developing and implementing strategies to support individuals with disabilities affected by substance use disorders.As a Disability Support Strategist, you will be responsible for case...


  • Calgary, Alberta, Canada National Bank Full time

    About UsAt National Bank, we're a leader in the Canadian banking industry. Our commitment to innovation and customer satisfaction has earned us a reputation as a trusted partner for individuals and businesses alike.Job OverviewWe're seeking an experienced Treasury Solutions Strategist to join our Corporate & Investment Banking team. In this role, you'll be...


  • Calgary, Alberta, Canada Superior Propane Full time

    About the RoleWe are seeking an experienced and highly analytical professional to join our team as a Chief NGL Market Strategist. In this crucial role, you will be responsible for analyzing market trends, forecasting supply and demand, and preparing, maintaining, and distributing daily commodity marketing pricing reports.Key ResponsibilitiesConduct in-depth...


  • Calgary, Alberta, Canada HUB International Full time

    Role OverviewThe Chief Compliance Officer will play a pivotal role in ensuring HUB Capital operates within the boundaries of regulatory requirements and industry standards. This individual will provide strategic leadership to the HUB Management team and oversee the national compliance program across Canada, encompassing risk management, policies, procedures,...


  • Calgary, Alberta, Canada Dehavilland Full time

    OverviewDe Havilland Aircraft of Canada Limited is a renowned aerospace company with a rich history of innovation and quality. With a global presence, we are committed to delivering exceptional products and services that meet the highest standards.Salary: CAD $120,000 - $180,000 per annum, depending on experience.Job DescriptionThe Director, Airworthiness...


  • Calgary, Alberta, Canada VHR Executive Full time

    Experience a new level of financial leadership as you join VHR Executive as Chief Financial Strategist. In this pivotal role, you will guide the company's financial direction, overseeing key responsibilities such as financial planning, budgeting, forecasting, and reporting.Key Responsibilities:Financial Leadership: Leverage your expertise to develop and...


  • Calgary, Alberta, Canada City of Calgary Full time

    City of CalgaryWe are committed to fostering a respectful, inclusive and equitable workplace which is representative of the community we serve.A challenging opportunity has arisen for a highly skilled professional to lead the development of climate and environmental strategies across the corporation. As the Leader, Governance and Reporting in Climate &...