Regulatory Affairs Specialist

4 weeks ago


Sherbrooke, Quebec, Canada bioMérieux Full time

Primary Purpose and Overall Objective of the Job:

Develop regulatory strategy of similar and new products and execute regulatory processes as planned.

Main Accountabilities:

  • Conduct research on regulatory changes and developments and on application requirements and process,
  • Assist in the development and review of procedures,
  • Advise responsible personnel on regulatory requirements and develop options with recommendations; develop product regulatory strategy; assess continuously project output and impact on regulatory strategy and launch date,
  • Validate product labels, instructions for use, advertising and promotional materials,
  • Compile and organize content of regulatory applications and files; assess acceptability and completeness of documents; identify unmet needs and provide feedback; ensure filing and timely retrieval
  • Interact with regulatory authorities and execute regulatory processes; provide feedback on application review progress and questions; coordinate and review answers to questions; report on issues.

Studies-Experience:

  • Master's degree in Engineering or Life Science
    • Software Engineering or Microbiology preferred
  • Knowledge of regulatory requirements, guidance documents and processes (local/regional) with more than 5 years of practice in the field of IVD/MD in an international environment,
    • Experience with ISO 13485, ISO 14791, ISO 27001 or ISO 27002 are highly preferred
    • Experience with FDA and/or Health Canada preferred
  • Regulatory knowledge : Strong understanding of regulations and standards such as FDA, EMA, (EU) MDR EU2017/745, IVDR EU2017/746, ISO 13485, HIPAA and RGPD.
  • Familiar with local regulatory agency organization,

  • Mortgage Specialist

    2 months ago


    Sherbrooke, Quebec, Canada BMO Full time

    Application Deadline:05/30/2024Address:4857 boul Bourque, #11Job Family Group:Retail Banking Sales & ServiceCultivates, builds, and manages relationships with a third-party network of referral sources to build a pipeline of new mortgage business and increase BMO's share of the home financing market. Actively identifies sales opportunities and refers to BMO...


  • Sherbrooke, Quebec, Canada Wolters Kluwer N.V. Full time

    Product Software Engineer- Bilingual- Backend Developer page is loaded Product Software Engineer- Bilingual- Backend Developer Apply locations CAN - Sherbrooke time type Full time posted on Posted 2 Days Ago job requisition id R Under direct supervision, assists in designing, developing, testing, debugging and implementing operating systems components,...


  • Sherbrooke, Canada bioMérieux Full time

    Primary Purpose and Overall Objective of the Job: Develop regulatory strategy of similar and new products and execute regulatory processes as planned.   Main Accountabilities: Conduct research on regulatory changes and developments and on application requirements and process, Assist in the development and review of procedures, Advise responsible...


  • Sherbrooke, Canada bioMérieux Full time

    Primary Purpose and Overall Objective of the Job: Develop regulatory strategy of similar and new products and execute regulatory processes as planned.   Main Accountabilities: Conduct research on regulatory changes and developments and on application requirements and process, Assist in the development and review of procedures, Advise responsible...


  • Sherbrooke, Canada PASQAL Full time

    **Legal Contract Specialist - Sherbrooke, QC Canada, ONSITE ONLY, Full time** PASQAL has partnerships with key users in the fields of energy, IT, finance, drug and chemical design, automotive. The maturity and potential of our technology and the quality of our scientific team has been rewarded several times at French, European and global levels. As a...


  • Sherbrooke, Canada Global Excel Management Full time

    **Job Description**: Are you a person with organizational and analytical skills? Are you interested in working in a multilingual, dynamic and friendly environment that encourages personal and professional development? We would love to meet you! As a Pension and Benefits Specialist, you will play a critical role in managing and administering employee...

  • Packaging Specialist

    3 weeks ago


    Sherbrooke, Canada ARTURUS Full time

    **Job Summary**: As a Packaging Specialist with expertise in translation, you will play a crucial role in ensuring accurate and culturally sensitive packaging for products targeted at diverse markets. **Key Responsibilities**: Multilingual Packaging: - Translate and adapt packaging content, including labels, instructions, and marketing materials, into...

  • Product Specialist

    4 weeks ago


    Sherbrooke, Canada Syneos Health Clinical Full time

    **Description** **JOB SUMMARY**: The role of the Product Specialist (PS) will be to support the launch a new product across Canada in the insomnia market. Within their assigned territory the PS will be responsible for bringing about understanding of the role of the product and its data in helping patients with insomnia by calling on GP/FM and specialists...

  • Mortgage Specialist

    5 days ago


    Sherbrooke, Canada BMO Financial Group Full time

    4857 boul Bourque, #11 Sherbrooke Quebec,J1N 1E8 Cultivates, builds, and manages relationships with a third-party network of referral sources to build a pipeline of new mortgage business and increase BMO’s share of the home financing market. Actively identifies sales opportunities and refers to BMO colleagues as appropriate. Develops and executes...

  • Mortgage Specialist

    2 months ago


    Sherbrooke, Canada BMO Full time

    Application Deadline: 04/18/2024Address:4857 boul Bourque, #11Cultivates, builds, and manages relationships with a third-party network of referral sources to build a pipeline of new mortgage business and increase BMO's share of the home financing market. Actively identifies sales opportunities and refers to BMO colleagues as appropriate. Develops and...

  • Mortgage Specialist

    4 weeks ago


    Sherbrooke, Canada BMO Full time

    Application Deadline: 04/18/2024Address:4857 boul Bourque, #11Cultivates, builds, and manages relationships with a third-party network of referral sources to build a pipeline of new mortgage business and increase BMO's share of the home financing market. Actively identifies sales opportunities and refers to BMO colleagues as appropriate. Develops and...

  • Mortgage Specialist

    2 months ago


    Sherbrooke, Canada BMO Full time

    Application Deadline: 05/30/2024 Address: 4857 boul Bourque, #11 Job Family Group: Retail Banking Sales & Service Cultivates, builds, and manages relationships with a third-party network of referral sources to build a pipeline of new mortgage business and increase BMO’s share of the home financing market. Actively identifies sales opportunities and refers...

  • Mortgage Specialist

    4 weeks ago


    Sherbrooke, Canada BMO Full time

    Application Deadline: 05/30/2024 Address: 4857 boul Bourque, #11 Job Family Group: Retail Banking Sales & Service Cultivates, builds, and manages relationships with a third-party network of referral sources to build a pipeline of new mortgage business and increase BMO’s share of the home financing market. Actively identifies sales opportunities and refers...


  • Sherbrooke, Canada BMO Financial Group Full time

    955 King Street East Sherbrooke Quebec,J1G 1E3 Delivers exceptional service to BMO customers and prospects. Identifies customer needs and provides advice and guidance regarding financial solutions that are in the best interests of customers. Works collaboratively within the branch and with BMO partners to deliver the desired customer experience and achieve...


  • Sherbrooke, Canada BMO Financial Group Full time

    2959 rue King ouest Sherbrooke Quebec,J1L 1C7 Delivers exceptional service to BMO customers and prospects. Identifies customer needs and provides advice and guidance regarding financial solutions that are in the best interests of customers. Works collaboratively within the branch and with BMO partners to deliver the desired customer experience and achieve...


  • Sherbrooke, Canada BMO Financial Group Full time

    955 King Street East Sherbrooke Quebec,J1G 1E3 Delivers exceptional service to BMO customers and prospects. Identifies customer needs and provides advice and guidance regarding financial solutions that are in the best interests of customers. Works collaboratively within the branch and with BMO partners to deliver the desired customer experience and achieve...


  • Sherbrooke, Canada BMO Financial Group Full time

    2959 rue King ouest Sherbrooke Quebec,J1L 1C7 Delivers exceptional service to BMO customers and prospects. Identifies customer needs and provides advice and guidance regarding financial solutions that are in the best interests of customers. Works collaboratively within the branch and with BMO partners to deliver the desired customer experience and achieve...

  • Investment Specialist

    4 weeks ago


    Sherbrooke, Canada BMO Financial Group Full time

    2959 rue King ouest Sherbrooke Quebec,J1L 1C7 Provides financial and investment planning and advice to deliver a solution in the best interests of the customer. Determines client needs and provides solutions though the sales of managed products and services (e.g. mutual funds, retirement savings plans, and similar products). Provides other solutions...


  • Sherbrooke, Canada Wolters Kluwer N.V. Full time

    Wolters Kluwer vous offre : EXIGENCES : ATOUTS:  Summary: We are looking for someone with a passion for taxation who wants to work in an unconventional environment where they will participate to the development and release of high-performance, state-of-the-art tax software. The incumbent will work within the team responsible for the quality...


  • Sherbrooke, Canada Wolters Kluwer N.V. Full time

    Wolters Kluwer vous offre : EXIGENCES : ATOUTS:  Summary: We are looking for someone with a passion for taxation who wants to work in an unconventional environment where they will participate to the development and release of high-performance, state-of-the-art tax software. The incumbent will work within the team responsible for the quality...


  • Sherbrooke, Canada Wolters Kluwer N.V. Full time

    Product Software Engineer- Bilingual- Backend Developer page is loaded Product Software Engineer- Bilingual- Backend Developer Apply locations CAN - Sherbrooke time type Full time posted on Posted 2 Days Ago job requisition id R0040024 Under direct supervision, assists in designing, developing, testing,...


  • Sherbrooke, Canada Wolters Kluwer N.V. Full time

    Product Software Engineer- Bilingual- Backend Developer page is loaded Product Software Engineer- Bilingual- Backend Developer Apply locations CAN - Sherbrooke time type Full time posted on Posted 2 Days Ago job requisition id R0040024 Under direct supervision, assists in designing, developing, testing,...