Regulatory Affairs Specialist

1 week ago

Calgary, Canada Fluid Biomed Inc. Full time

This is a full-time opportunity to join the technical team of an early-stage company to support the development and commercialization of a novel implantable medical device. Fluid Biomed is an innovative medical device startup focused on developing a cutting-edge neurovascular stent to treat brain aneurysms and enhance patient outcomes worldwide.


Position Summary:

As a Regulatory Affairs Specialist, you will play a crucial role in the preparation and submission of FDA pre-submissions, Investigational Device Exemptions (IDE), Pivotal Study applications, and Premarket Approval (PMA) submissions for Class III implantable devices.


Key Responsibilities:

  • Develop regulatory strategies for Class III implantable devices, ensuring compliance with applicable regulations and standards.
  • Lead the preparation and submission of FDA pre-submission documents, clinical trial protocols, and PMA applications.
  • 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.
  • Collaborate with engineering, preclinical, clinical, and quality assurance teams to gather necessary documentation and data for submissions.
  • Collaborate with team to provide regulatory requirement inputs in developing technical and regulatory documents (e.g., SSED as well as verification test methods and protocols)
  • Assist in preparing responses to regulatory authorities’ questions within assigned timelines.
  • Assess and document regulatory impact of product design changes in jurisdictions where product is licensed.
  • Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.
  • Maintain quality procedures related to regulatory responsibilities, participate in internal audits, and support post-market surveillance activities.
  • Coordinate with external consultants and regulatory agencies as needed. Stay abreast of regulatory procedures, guidance documents, standards, and changes in regulatory climate.
  • Maintain up-to-date knowledge of regulatory changes and industry trends.
  • Support creation of protocols and supporting documentation for early feasibility studies and clinical trials.
  • Experience with packaging regulations and labeling for the final product according to the target jurisdictions.


Education: Minimum of Bachelor’s degree in Biological Sciences, Biochemistry, Chemistry, Toxicology, Pharmacy, Medicine, Engineering, Pharmacology or related field.


Qualifications:

  • 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.
  • Demonstrated ability to digest detailed data while maintaining a view of the big picture.
  • Strong data analysis skills.
  • Excellent written and verbal communication skills with the ability to listen, articulate and advocate.
  • Documented training on current medical device standards and regulations is an asset (e.g. MDSAP, EU MDR, ISO 13485, etc.).
  • Demonstrated skill at managing multiple projects and deadlines.
  • Ability to work effectively in a demanding environment with strict timelines and operating procedures.


Additional Attributes:

  • The incumbent should be proactive and results-oriented with high attention to detail and strong project management and organizational skills.
  • Proficiency in MS Office applications, databases, and efficient online research.


  • Regulatory Affairs Specialist

    4 weeks ago

    Calgary, Canada Fluid Biomed Inc. Full time

    This is a full-time opportunity to join the technical team of an early-stage company to support the development and commercialization of a novel implantable medical device. Fluid Biomed is an innovative medical device startup focused on developing a cutting-edge neurovascular stent to treat brain aneurysms and enhance patient outcomes worldwide. Position...

  • Regulatory Affairs Specialist

    4 weeks ago

    Calgary, Canada Fluid Biomed Inc. Full time

    This is a full-time opportunity to join the technical team of an early-stage company to support the development and commercialization of a novel implantable medical device. Fluid Biomed is an innovative medical device startup focused on developing a cutting-edge neurovascular stent to treat brain aneurysms and enhance patient outcomes worldwide.Position...

  • Regulatory Affairs Specialist

    3 weeks ago

    Calgary, Canada Fluid Biomed Inc. Full time

    This is a full-time opportunity to join the technical team of an early-stage company to support the development and commercialization of a novel implantable medical device. Fluid Biomed is an innovative medical device startup focused on developing a cutting-edge neurovascular stent to treat brain aneurysms and enhance patient outcomes worldwide.Position...

  • Regulatory Affairs Strategist

    3 weeks ago

    Calgary, Alberta, Canada Fluid Biomed Inc. Full time

    Job OverviewWe 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...

  • Regulatory Affairs Specialist

    3 weeks ago

    Calgary, AB, Canada Fluid Biomed Inc. Full time

    This is a full-time opportunity to join the technical team of an early-stage company to support the development and commercialization of a novel implantable medical device. Fluid Biomed is an innovative medical device startup focused on developing a cutting-edge neurovascular stent to treat brain aneurysms and enhance patient outcomes worldwide. Position...

  • Regulatory Affairs Specialist

    4 weeks ago

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

    This is a full-time opportunity to join the technical team of an early-stage company to support the development and commercialization of a novel implantable medical device. Fluid Biomed is an innovative medical device startup focused on developing a cutting-edge neurovascular stent to treat brain aneurysms and enhance patient outcomes worldwide.Position...

  • Regulatory Affairs Specialist

    4 weeks ago

    Calgary, AB, Canada Fluid Biomed Inc. Full time

    This is a full-time opportunity to join the technical team of an early-stage company to support the development and commercialization of a novel implantable medical device. Fluid Biomed is an innovative medical device startup focused on developing a cutting-edge neurovascular stent to treat brain aneurysms and enhance patient outcomes worldwide. Position...

  • Regulatory Affairs Expert

    3 weeks ago

    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...

  • Regulatory Affairs Strategist

    3 weeks ago

    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...

  • Regulatory Affairs Officer

    6 months ago

    Calgary, Canada Alberta Teachers Association Full time

    **The Alberta Teachers’ Association** **Regulatory Affairs Officer** Full-Time Position Work Location: South Alberta Regional Officer (SARO) 350, 6815 8th Street NE, Calgary AB T2E 7H7 Position Start Date: Early August As the professional organization of Alberta teachers, the ATA promotes and advances public education, supports teachers’...

  • Regulatory Affairs Director

    2 weeks ago

    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...

  • Regulatory Affairs Analyst

    7 months ago

    Calgary, Canada Alberta Veterinary Laboratories Ltd Full time

    **WE’RE HIRING!** **OUR MISSION** At Alberta Veterinary Laboratories/Solvet (‘AVL/Solvet’), our multi-faceted team is dedicated to promoting the health and welfare of animals. Built on the values of **INNOVATION**, **QUALITY**, **PEOPLE/ANIMALS**, **ACCOUNTABILITY**, **PASSION**, and **SAFETY**, AVL is a Canadian company searching for new solutions...

  • Advisor Regulatory Affairs

    2 months ago

    Calgary, Canada Enbridge Full time

    **Posting End Date**: November 08, 2024 **Employee Type**: Regular-Full time **Union/Non**: This is a non-union position We are seeking an Advisor Regulatory Affairs to join our team! The primary focus of this role is leading, organizing, monitoring, and making regulatory filings related to operations and maintenance activities and routine projects. We...

  • Director, Regulatory Affairs

    3 weeks ago

    Calgary, Canada Government of Alberta Full time

    **Job Information** Job Requisition ID: 65064 Ministry: Energy and Minerals Location: Edmonton/Calgary Full or Part-Time: Full-Time Hours of Work: 36.25 hours per week Permanent/Temporary: Permanent Scope: Open Competition Closing Date: December 16, 2024 Classification: Management Senior Manager Zone 2 **Salary**: $3,548.95 to $5,427.68 bi-weekly...

  • Regulatory Affairs Expert

    2 weeks ago

    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...

  • Coordinator, Regulatory and External Affair

    3 months ago

    Calgary, Canada TRANS-NORTHERN PIPELINES Full time

    **ABOUT US** Trans-Northern Pipelines Inc. (TNPI) operates regulated pipelines to safely transport the refined petroleum products (gasoline, diesel, aviation, and heating fuel) used by Canadian businesses and consumers every day. These pipelines connect refineries in Edmonton to Calgary, including the Calgary International Airport; and refineries in...

  • Manager, Regulatory

    2 months ago

    Calgary, Canada MEG Energy Full time

    Job Posting End Date: Saturday, November 16, 2024 Position Type: Employee Position Sub Type: Permanent Full Time Work Location: Calgary, AB Shift: Office Hours (Canada) __________________________ At MEG, you can bring your unique knowledge and experience to work and contribute your ideas to drive our purpose is to supply the world with energy, produced...

  • Emissions and Regulatory Specialist

    3 weeks ago

    Calgary, Alberta, Canada Intricate Full time

    Our company, Intricate, is seeking an experienced Emissions and Regulatory Specialist to join our team in Calgary, AB. This full-time role involves conducting emissions quantification, developing emission reduction strategies, and implementing solutions to improve the emissions and regulatory performance of our clients. We are looking for a detail-oriented...

  • Regulatory Law Specialist

    3 weeks ago

    Calgary, Alberta, Canada AltaLink Full time

    Job OverviewAltaLink, a leading electricity transmission and distribution company in Canada, is seeking an experienced Regulatory Law Specialist to join their Law and Regulatory Group.About the RoleWe are looking for a skilled regulatory lawyer with 2-5 years of experience in energy law or a related field. The successful candidate will provide legal...

  • Compliance Director

    3 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...