Current jobs related to Regulatory Affairs Specialist - Kingston Ontario AK, Lennox and Addington - Adecco

  • Regulatory Affairs Specialist

    2 days ago

    Ottawa, Ontario, Ottawa region, Canada Altis Recruitment Full time

    Altis Recruitment is seeking a detail-oriented and proactive Clinical Research Regulatory Specialist to join our client in the pharmaceutical industry. In this role, you will oversee and ensure adherence to clinical study regulations as outlined by pharmaceutical sponsors, regulatory authorities, ethics review boards, and other stakeholders.You will play a...

  • Director of Regulatory Affairs

    2 days ago

    Ottawa, Ontario, Ottawa region, Canada Altis Recruitment Full time

    Altis Recruitment is seeking a Director, Regulatory Affairs for our client in the pharmaceutical industry. The successful incumbent will oversee and ensure compliance of all clinical studies with relevant regulations, aligning with the organization’s mission, values, and strategic goals. This position will lead the Regulatory Affairs team, providing...

  • Regulatory Compliance Specialist

    3 weeks ago

    Kingston, Ontario, Canada Canada Royal Milk ULC Full time

    Job Title: Regulatory Compliance SpecialistCanada Royal Milk ULC is seeking a highly skilled Regulatory Compliance Specialist to join our team.Job SummaryThe Regulatory Compliance Specialist will be responsible for ensuring that our company's operations comply with all relevant laws, regulations, and industry standards.Key ResponsibilitiesAnalyze and provide...

  • Regulatory Compliance Specialist

    1 month ago

    Kingston, Ontario, Canada Canada Royal Milk ULC Full time

    Job Title: Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Canada Royal Milk ULC.Key Responsibilities:Analyze and provide advice on managerial methods and organization of our establishment to ensure compliance with regulatory requirements.Conduct quality audits to identify areas for...

  • Regulatory Compliance Specialist

    4 weeks ago

    Kingston, Ontario, Canada Canada Royal Milk ULC Full time

    Job Title: Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Canada Royal Milk ULC.Key Responsibilities:Analyze and provide advice on managerial methods and organization of our establishment to ensure compliance with regulatory requirements.Conduct quality audits to identify areas for...

  • Regulatory Compliance Specialist

    3 weeks ago

    Kingston, Ontario, Canada Canada Royal Milk ULC Full time

    Job Title: Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Canada Royal Milk ULC.Key Responsibilities:Analyze and provide advice on managerial methods and organization of our establishment to ensure compliance with regulatory requirements.Conduct quality audits to identify areas for...

  • Regulatory Compliance Specialist

    1 month ago

    Kingston, Ontario, Canada Canada Royal Milk ULC Full time

    Job Title: Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Canada Royal Milk ULC. As a key member of our organization, you will be responsible for ensuring that our business practices and operations comply with relevant laws, regulations, and industry standards.Key Responsibilities:Analyze...

  • Regulatory Compliance Specialist

    4 weeks ago

    Kingston, Ontario, Canada Canada Royal Milk ULC Full time

    Job Title: Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Canada Royal Milk ULC. As a key member of our organization, you will be responsible for ensuring that our business practices and operations comply with relevant laws, regulations, and industry standards.Key Responsibilities:Analyze...

  • Regulatory Compliance Specialist

    4 weeks ago

    Kingston, Ontario, Canada Canada Royal Milk ULC Full time

    Job Title: Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Canada Royal Milk ULC. As a key member of our organization, you will be responsible for ensuring that our business practices and operations comply with relevant laws, regulations, and industry standards.Key Responsibilities:Analyze...

  • Regulatory Compliance Specialist

    1 month ago

    Kingston, Ontario, Canada Canada Royal Milk ULC Full time

    Job Title: Regulatory Compliance SpecialistCanada Royal Milk ULC is seeking a highly skilled Regulatory Compliance Specialist to join our team. As a key member of our organization, you will play a critical role in ensuring our operations comply with relevant laws, regulations, and industry standards.Key Responsibilities:Analyze and provide advice on...

  • Regulatory Compliance Specialist

    4 weeks ago

    Kingston, Ontario, Canada Canada Royal Milk ULC Full time

    Job Title: Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Canada Royal Milk ULC. As a key member of our organization, you will play a critical role in ensuring our operations comply with relevant laws, regulations, and industry standards.Key Responsibilities:Analyze and provide advice on...

  • Regulatory Compliance Specialist

    4 weeks ago

    Kingston, Ontario, Canada Canada Royal Milk ULC Full time

    Job Title: Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Canada Royal Milk ULC. As a key member of our organization, you will play a critical role in ensuring our operations comply with relevant laws, regulations, and industry standards.Key Responsibilities:Analyze and provide advice on...

  • Regulatory Compliance Specialist

    1 month ago

    Kingston, Ontario, Canada Canada Royal Milk ULC Full time

    Job Title: Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Canada Royal Milk ULC. As a key member of our organization, you will play a critical role in ensuring our operations comply with relevant laws, regulations, and industry standards.Key Responsibilities:Analyze and provide advice on...

  • Regulatory Compliance Specialist

    1 month ago

    Kingston, Ontario, Canada Canada Royal Milk ULC Full time

    Job Title: Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Canada Royal Milk ULC. As a key member of our organization, you will play a critical role in ensuring our operations comply with relevant laws, regulations, and industry standards.Key Responsibilities:Analyze and provide advice on...

  • Regulatory Compliance Specialist

    1 month ago

    Kingston, Ontario, Canada Canada Royal Milk ULC Full time

    Job Title: Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Canada Royal Milk ULC. As a key member of our organization, you will play a critical role in ensuring our operations comply with relevant laws, regulations, and industry standards.Key Responsibilities:Analyze and provide advice on...

  • Regulatory Compliance Specialist

    4 weeks ago

    Kingston, Ontario, Canada Canada Royal Milk ULC Full time

    Job Title: Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Canada Royal Milk ULC. As a key member of our organization, you will play a critical role in ensuring our operations comply with relevant laws, regulations, and industry standards.Key Responsibilities:Analyze and provide advice on...

  • Regulatory Compliance Specialist

    4 weeks ago

    Kingston, Ontario, Canada Canada Royal Milk ULC Full time

    Job Title: Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Canada Royal Milk ULC. As a key member of our organization, you will play a critical role in ensuring our operations comply with relevant laws, regulations, and industry standards.Key Responsibilities:Analyze and provide advice on...

  • Regulatory Compliance Specialist

    1 month ago

    Kingston, Ontario, Canada Canada Royal Milk ULC Full time

    Job Title: Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Canada Royal Milk ULC. As a key member of our organization, you will play a critical role in ensuring our operations comply with relevant laws, regulations, and industry standards.Key Responsibilities:Analyze and provide advice on...

  • Regulatory Compliance Specialist

    2 weeks ago

    Kingston, Ontario, Canada Canada Royal Milk ULC Full time

    Job Summary: We are seeking a highly skilled Regulatory Compliance Specialist to join our team at Canada Royal Milk ULC. The successful candidate will be responsible for analyzing and providing advice on managerial methods and organization of our establishment, conducting quality audits, and developing quality management and quality assurance standards.Key...

  • Regulatory Compliance Specialist

    1 week ago

    Kingston, Ontario, Canada Canada Royal Milk ULC Full time

    Job SummaryCanada Royal Milk ULC is seeking a highly skilled Regulatory Compliance Specialist to join our team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and developing quality management and quality assurance standards.Key ResponsibilitiesAnalyze and provide advice on managerial methods...

Regulatory Affairs Specialist

3 months ago

Kingston Ontario AK, Lennox and Addington, Canada Adecco Full time

Adecco is currently hiring a full-time Regulatory Affairs Specialist with a specialization in customer service to work for our client, who is dedicated to innovation and excellence, in Stouffville, ON. This role is essential in ensuring compliance with regulatory requirements and supporting the development and approval of our clients' products. In this role you will be responsible for managing and overseeing regulatory submissions, ensuring compliance with applicable regulations, and providing regulatory guidance to various departments.

If you have a strong understanding of regulatory requirements, excellent organizational skills, strong customer service skills and the ability to manage multiple projects simultaneously, apply today

  • Pay Rate: $28.00/hour
  • Location: Stouffville, ON
  • Shift: 8:00am - 4:30pm
  • Job type: Full-time | Short term with the possibility of extension
Here's why you should apply:
  • Paid weekly accurate and on time
  • Strong health and safety programs
  • Medical and dental benefits once qualified
  • Free training programs
  • New and quicker onboarding process
Responsibilities:
  • Maintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned such as regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required.
  • Ensures a thorough understanding of the products and/or regions they are assigned.
  • Communicates country/region specific regulatory requirements of the regions they are assigned to the RA team.
  • Develop global regulatory strategies for company medical devices in collaboration with other regulatory affairs or clinical personnel (as applicable), especially on high-risk devices.
  • Advise other company functional units (engineering, marketing, operations, quality, biocompatibility etc) of the requirements in each target market.
  • Ensure the outputs from the individual functional units meet the applicable regulatory requirements.
  • Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as required.
  • Maintains registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.
  • Communication of the clinical requirements for regulatory registrations for the product and working as part of a cross functional team to ensure that they are adequately addressed.
  • Communicates directly with notified bodies, distribution partners, company affiliates and other regulatory authorities to ensure product approvals are achieved in a timely manner.
  • Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
  • Serves as a liaison on regulatory issues between the company Manufacturer and the company International local office and/or company distribution partner.
  • Provides support to currently marketed products as necessary including input on change requests, regulatory restrictions, etc.
  • Maintains and organizes appropriate regulatory records to demonstrate compliance with applicable regulations.
  • Provides regulatory support to company functional units such as the SSC, tenders, customer quality and distribution.
  • Performs additional duties as assigned. Can act as a designee for other Regulatory Affairs Specialists if required. Ensure that company Code of Conduct is considered in all business matters carried out on company's behalf.
Qualifications:
  • Must be legally eligible to work, and reside in Canada
  • Third level Qualification preferably in Science/Engineering; 3-5 years' experience in a regulated industry in a similar role desirable
  • Ideally have knowledge of requirements in MDSAP countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required.
  • Knowledge of medical device quality standards/practices or similar regulated industry.
  • Good communication and inter-personal skills.
  • Proven problem-solving skills.
  • Good computer skills including knowledge of Microsoft Office.
  • Proven organizational skills.
  • High self-motivation.
  • Willingness and availability to travel on company business.
  • Ability to prepare/assist with preparation of licensing applications based on scientific information and Health Canada guidance.
  • Preparation and submission of mandatory problem reports based on customer communication records and incident files.
  • Ability to work within an ISO 13485 / ISO 9001-style Quality Management System and update Standard Operation Procedures / Work Instructions as needed.
  • Preparation of recall communications and execution of recalls based on manufacturer-provided information.
  • Interface with inventory management system and databases for tracking Custom-Made Device orders and authorizations.
  • Superior communication / customer service skills - communication with internal and external customers, and regulatory authorities.

Are you interested in this position? Apply now Our dynamic team of recruiters will reach out if you qualify for this role.

#J-18808-Ljbffr