Regulatory Affairs Senior Manager

3 weeks ago

Vancouver, British Columbia, Canada TalentSphere Staffing Solutions Full time

Job Title: Senior Manager, Regulatory Affairs

Company: TalentSphere Staffing Solutions

Job Type: Full-time

Location: Remote

Job Description:

We are seeking an experienced Senior Manager to lead our Regulatory Affairs team. The successful candidate will have a proven track record of developing and executing global regulatory plans, leading regulatory submissions, and ensuring compliance with regulatory requirements.

Key Responsibilities:

  • Develop and execute global regulatory plans to obtain clinical and commercial approvals for new products and existing product changes.
  • Lead and support US and global health agency meetings, health agency inquiries, and global filing activities.
  • Support IVD design and development activities, quality compliance activities, and documentation reviews.
  • Perform regulatory reportability assessments and stay abreast of changes in device-related standards and guidance.
  • Develop internal best practices and lead process improvement activities in close collaboration with the business leaders.
  • Support IVD supplier engagement and due diligence activities; review regulatory information in quality and supply agreements with partners and suppliers.
  • Work closely with R&D, product development, and operations teams to ensure regulatory compliance throughout development and production.

Qualifications:

  • M.Sc. degree or equivalent with 10 or more years of regulatory experience in the diagnostics or medical device industries.
  • Strong knowledge and experience with US FDA regulatory applications, ongoing reporting requirements, concepts, and methods.
  • Solutions-oriented focus to addressing and overcoming regulatory challenges that seeks to minimize time to market and maximize patient access.
  • Previous experience in leading, drafting, and submitting an IVD 510(k) application with the US FDA.
  • Previous experience leading regulatory submissions and reporting outside the United States, including CE mark, UKCA, and Health Canada applications.
  • Local market knowledge with developed network of contacts with CROs, CMOs, and regulatory bodies.
  • RAPS RAC for Canada and US and RAC-Devices will be considered an asset.
  • ISO 13485 knowledge and experience will be considered an asset.
  • Superior computer proficiency (MS Office Suite, Adobe Acrobat or equivalent); aptitude and desire to learn new computer applications.
  • Exceptional communication and teamwork skills.
  • Collaborative worker with an ability to support a high-performing team, be a problem-solver, with a positive attitude, and able to work in a dynamic environment.

What We Offer:

  • Competitive salary and benefits package.
  • Opportunity to work with a dynamic and growing company.
  • Chance to make a real impact in the regulatory affairs field.

How to Apply: If you are a motivated and experienced regulatory affairs professional looking for a new challenge, please submit your resume and cover letter to [removed contact information].

  • Regulatory Affairs Senior Manager

    3 weeks ago

    Vancouver, British Columbia, Canada TalentSphere Staffing Solutions Full time

    Job Title: Senior Manager, Regulatory AffairsOur client, a commercial stage diagnostics company, is seeking a Senior Manager, Regulatory Affairs to join their team. As a key member of the organization, you will be responsible for working directly with the Global Head of Product R&D and external regulatory consultants on FDA 510(k) submissions for current and...

  • Regulatory Affairs Senior Manager

    3 weeks ago

    Vancouver, British Columbia, Canada TalentSphere Staffing Solutions Full time

    Job Title: Senior Manager, Regulatory AffairsJob Summary: We are seeking a highly experienced Senior Manager, Regulatory Affairs to join our team at TalentSphere Staffing Solutions. The successful candidate will be responsible for developing and executing global regulatory plans to obtain clinical and commercial approvals for new products and existing...

  • Regulatory Affairs Manager

    1 month ago

    Vancouver, British Columbia, Canada TalentSphere Staffing Solutions Full time

    Job Title: Senior Manager, Regulatory AffairsOur client, a commercial stage diagnostics company, is seeking a Senior Manager, Regulatory Affairs to join their team. As a key member of the organization, you will be responsible for working directly with the Global Head of Product R&D and external regulatory consultants on FDA 510(k) submissions for current and...

  • Senior Vice President, Regulatory Affairs

    2 months ago

    Vancouver, British Columbia, Canada Women in Payments Full time $203,000 - $377,000

    {"title": "Senior Vice President, Regulatory Affairs", "content": "OverviewClio is seeking a highly skilled and experienced Senior Vice President, Regulatory Affairs to lead our Financial Services organization. As a key member of our senior leadership team, you will be responsible for shaping and executing our financial services strategy, focusing on...

  • Regulatory Affairs Specialist

    2 weeks ago

    Vancouver, British Columbia, Canada Connor, Clark & Lunn Investment Management Ltd. Full time

    We are seeking a highly skilled Regulatory Affairs Associate to join our team at Connor, Clark & Lunn Investment Management Ltd. The ideal candidate will have a Bachelor's degree and 2-3 years of experience in regulatory affairs, preferably in a financial management or investment company setting.The Regulatory Affairs Associate will be responsible for...

  • Regulatory Affairs Manager

    4 weeks ago

    Vancouver, British Columbia, Canada TalentSphere Staffing Solutions Full time

    Job Title: Sr. Manager, Regulatory AffairsJob Summary:TalentSphere Staffing Solutions is seeking a highly skilled Sr. Manager, Regulatory Affairs to join our team. As a key member of our organization, you will be responsible for developing and executing global regulatory plans to obtain clinical and commercial approvals for new products and existing product...

  • Regulatory Affairs Specialist

    4 weeks ago

    Vancouver, British Columbia, Canada Connor, Clark & Lunn Investment Management Ltd. Full time

    Regulatory Affairs AssociateWe are seeking a highly motivated and detail-oriented Regulatory Affairs Associate to join our team at Connor, Clark & Lunn Investment Management Ltd.Key Responsibilities:Assist in the development and implementation of regulatory strategies to ensure compliance with relevant laws and regulations.Conduct research and analysis on...

  • Regulatory Affairs Specialist

    1 month ago

    Vancouver, British Columbia, Canada Connor, Clark & Lunn Investment Management Ltd. Full time

    Regulatory Affairs AssociateWe are seeking a highly motivated and detail-oriented Regulatory Affairs Associate to join our team at Connor, Clark & Lunn Investment Management Ltd.Key Responsibilities:Assist in the development and implementation of regulatory compliance strategies and procedures.Monitor and analyze regulatory changes and updates to ensure...

  • Regulatory Affairs Specialist

    3 weeks ago

    Vancouver, British Columbia, Canada Connor, Clark & Lunn Investment Management Ltd. Full time

    We are seeking a Regulatory Affairs Associate to join our team at Connor, Clark & Lunn Investment Management Ltd. This role will be responsible for ensuring compliance with regulatory requirements and providing support to the investment management team.Key Responsibilities:Ensure compliance with regulatory requirements and industry standardsProvide support...

  • Regulatory Affairs Specialist

    3 weeks ago

    Vancouver, British Columbia, Canada Connor, Clark & Lunn Investment Management Ltd. Full time

    We are seeking a highly skilled Regulatory Affairs Associate to join our team at Connor, Clark & Lunn Investment Management Ltd. This role will be responsible for ensuring compliance with regulatory requirements and providing support to the investment management team.Key Responsibilities:Ensure compliance with regulatory requirements and industry...

  • Regulatory Affairs Specialist

    4 weeks ago

    Vancouver, British Columbia, Canada Connor, Clark & Lunn Investment Management Ltd. Full time

    We are seeking a highly motivated Regulatory Affairs Specialist to join our team at Connor, Clark & Lunn Investment Management Ltd. The successful candidate will be responsible for ensuring compliance with regulatory requirements and providing support to the investment management team.Key Responsibilities:Assist in the development and implementation of...

  • Regulatory Affairs Specialist

    4 weeks ago

    Vancouver, British Columbia, Canada Connor, Clark & Lunn Investment Management Ltd. Full time

    We are seeking a highly skilled Regulatory Affairs Associate to join our team at Connor, Clark & Lunn Investment Management Ltd. This role will be responsible for ensuring compliance with regulatory requirements and providing support to the investment management team.Key Responsibilities:Assist in the development and implementation of regulatory compliance...

  • Regulatory Affairs Specialist

    4 weeks ago

    Vancouver, British Columbia, Canada Connor, Clark & Lunn Investment Management Ltd. Full time

    Job SummaryWe are seeking a highly motivated Regulatory Affairs Specialist to join our team at Connor, Clark & Lunn Investment Management Ltd. The successful candidate will be responsible for ensuring compliance with regulatory requirements and providing support to the investment management team.Key ResponsibilitiesDevelop and implement compliance programs...

  • Regulatory Affairs Specialist

    3 weeks ago

    Vancouver, British Columbia, Canada Connor, Clark & Lunn Investment Management Ltd. Full time

    We are seeking a highly skilled Regulatory Affairs Associate to join our team at Connor, Clark & Lunn Investment Management Ltd. This role will be responsible for ensuring compliance with regulatory requirements and maintaining strong relationships with regulatory bodies.Key Responsibilities:Develop and implement regulatory compliance strategiesCollaborate...

  • Regulatory Affairs Specialist

    2 weeks ago

    Vancouver, British Columbia, Canada Connor, Clark & Lunn Investment Management Ltd.] Full time

    OverviewAt Connor, Clark & Lunn Investment Management Ltd., we are seeking a skilled Regulatory Affairs Associate to join our team. Key ResponsibilitiesWork closely with cross-functional teams to ensure compliance with regulatory requirements.Stay up-to-date with changes in regulatory laws and guidelines.Develop and implement effective compliance...

  • Regulatory Affairs Specialist

    3 weeks ago

    Vancouver, British Columbia, Canada Connor, Clark & Lunn Investment Management Ltd. Full time

    We are seeking a highly skilled Regulatory Affairs Associate to join our team at Connor, Clark & Lunn Investment Management Ltd. The successful candidate will have a Bachelor's degree and 2 years of experience in a related field.Key Responsibilities:Assist in the development and implementation of regulatory strategies to ensure compliance with relevant laws...

  • Regulatory Affairs Manager

    4 weeks ago

    Vancouver, British Columbia, Canada TalentSphere Staffing Solutions Full time

    Job SummaryWe are seeking a highly experienced Regulatory Affairs Manager to join our team at TalentSphere Staffing Solutions. As a key member of our organization, you will be responsible for developing and executing global regulatory plans to obtain clinical and commercial approvals for new products and existing product changes.Key Responsibilities:Develop...

  • Regulatory Affairs Expert

    1 day ago

    Vancouver, British Columbia, Canada Connor, Clark & Lunn Investment Management Ltd. Full time

    Job DescriptionWe are seeking a Regulatory Affairs Associate to join our team at Connor, Clark & Lunn Investment Management Ltd. This is a full-time position that offers a competitive salary and benefits package.Salary: $60,000 - $80,000 per year, depending on experienceThe successful candidate will have a strong background in regulatory affairs, with...

  • Regulatory Affairs Specialist

    1 week ago

    Vancouver, British Columbia, Canada Connor, Clark & Lunn Investment Management Ltd. Full time

    Job SummaryWe are seeking a highly motivated Regulatory Affairs Associate to join our team at Connor, Clark & Lunn Investment Management Ltd. The successful candidate will have a Bachelor's degree and 2 years of experience in a related field.Key ResponsibilitiesAssist in the development and implementation of regulatory compliance strategiesProvide support...

  • Regulatory Affairs Specialist

    1 day ago

    Vancouver, British Columbia, Canada College of Pharmacists of British Columbia Full time

    OverviewThe College of Pharmacists of British Columbia seeks a highly experienced Regulatory Affairs Specialist to join their team on a temporary basis for 20 months.