Current jobs related to Regulatory Affairs Specialist - WhitchurchStouffville - Adecco Canada

  • Network Architecture Specialist

    2 weeks ago

    Whitchurch–Stouffville, Ontario, Canada Scout Talent Inc Full time

    Network Design Manager RoleWe are seeking a highly skilled Network Design Manager to join our team at Scout Talent Inc. This is a fantastic opportunity for a seasoned professional to lead our network design efforts and drive business growth.Key ResponsibilitiesDevelop and implement network architecture designs that meet business requirements and ensure high...

  • Mortgage Specialist

    5 months ago

    Stouffville, Canada BMO Financial Group Full time

    18 Westlawn Cresent Stouffville Ontario,L4A 2S9 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 effective...

  • Personal Banking Associate

    5 months ago

    Stouffville, Canada BMO Financial Group Full time

    18 Westlawn Cresent Stouffville Ontario,L4A 2S9 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...

  • Customer Service Representative

    5 months ago

    Stouffville, Canada BMO Financial Group Full time

    18 Westlawn Cresent Stouffville Ontario,L4A 2S9 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...

  • Customer Service Representative

    4 months ago

    Stouffville, Canada BMO Financial Group Full time

    18 Westlawn Cresent Stouffville Ontario,L4A 2S9 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...

Regulatory Affairs Specialist

3 months ago

WhitchurchStouffville, Canada Adecco Canada 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 personal (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:
  • Mu st 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.
  • 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
CAO6659