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Medical Device Product Development jobs

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    • The successful candidate will provide support for new product development, ensuring Health Canada and customer requirements are being met, including labelling…
    • Participate in the design and development of medical devices.
    • Design, set up and perform tests to verify the viability and performance of medical devices.
    • Participate in the design and development of medical devices while following a quality system in accordance with ISO 13485.
    • Job Types: Full-time, Permanent.
    • As a Technical Product Manager, you will own product definition and technical product direction across hardware-driven development projects.
    • Instrumental in development through the entire process – including product formulation, sourcing ingredients & suppliers, developing prototypes, laboratory…
    • Manage integration activities involving connected clinical devices such as patient monitors, fetal monitors, dialysis, anesthesia-related devices, and other…
    • Selection of error and mistake proofing devices.
    • Responsible for programming torque control systems and joint development.
    • Experience in a regulated manufacturing environment (nuclear, aerospace, medical devices, or similar) is a strong asset.
    • Work with the business development team on product features and requirements.
    • Adjust mechanical devices such as transfer stages, manipulators, pneumatic…
    • Represents company at trade association meetings to promote products and services.
    • Partner with Training to ensure onboarding, competency, and continuous…
    • Work closely with software development, firmware, R&D, manufacturing, IT support, field support, and product stakeholders to challenge changes before release…
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    • Actively support proposal development through executive summary writeup, proposal structure guidance as well as scoping and solution development.
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    • Foster a culture of experimentation and rapid innovation, encouraging hypothesis-driven development and iterative learning.
    • Strong debugging skills, especially with Ethernet-connected devices.
    • Develop new firmware features based on product requirements and engineering specifications.
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    • Linking to Master device, adding device to Management tool and dashboard.
    • Maintain BAS automation network and understand development concepts.
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Job Post Details

Pharmaceutical Regulatory Affairs Specialist - job post

CRL Synergy
Calgary, AB T2S 1W3
$68,000–$100,000 a year - Full-time

Job details

Pay

  • $68,000–$100,000 a year

Job type

  • Full-time

Location

Calgary, AB T2S 1W3

Benefits

Pulled from the full job description

  • Paid time off
  • Vision care
  • Dental care
  • Life insurance
  • Disability insurance
  • On-site gym
  • Extended health care

Full job description

Job Overview
CRL Synergy, one of Canada’s largest and fastest-growing suppliers of control label products, is seeking a detail-oriented and proactive Regulatory Affairs (RAS) Specialist.CRL Synergy is seeking a Regulatory Affairs (RAS) Specialist who can thrive in a fast-paced environment that involves working in an office team environment.

The Regulatory Affairs Specialist is the site lead for all Health Canada submissions and post-market activities covering four product categories sold across Canada:

  • Drugs (DIN-assigned OTC)
  • Cosmetics
  • Medical Devices (Class I–II)
  • Natural Health Products (NHPs/NPNs)

The RAS plans, authors, files and maintains regulatory submissions and dossiers, and ensures compliant labelling/advertising.

This role will also provide quality assurance support through maintenance of the RA SOPs, ensuring they are current and implemented, perform data collection, and subsequent analysis.

The successful candidate will provide support for new product development, ensuring Health Canada and customer requirements are being met, including labelling accuracy for new and modified product.

Responsibilities

  • Oversight of Pharmacovigilance program

· Collaborate with cross-functional teams to implement corrective and preventive actions (CAPA) related to customer complaints.

· Participate in risk management activities and contribute to the development of risk assessment strategies.

  • Ensuring accurate record keeping and filing as per organizational procedures.
  • Handle clerical and administrative activities.
  • Review and assess customer complaints for adverse reactions and reportable incidents. Perform surveillance activities for ongoing product quality and safety.
  • Complete Annual Summary Reports and perform screening of scientific literature for product safety information.
  • Assisting in updating methods and procedures (SOPs) related to the Quality Management System with a focus on the customer complaint and pharmacovigilance program.

Qualifications

  • Bachelor’s degree in a relevant field; advanced degree preferred.
  • Proven experience in regulatory affairs or a related field, with a strong understanding of compliance requirements.
  • Demonstrated skills in project management, including the ability to manage multiple projects simultaneously.
  • Strong leadership abilities with experience in supervising teams or mentoring staff.
  • Excellent analytical skills with a focus on process improvement methodologies.
  • Familiarity with sales or business development processes is a plus.
  • Exceptional communication skills, both written and verbal, with the ability to effectively convey complex information to diverse audiences. Join us in making a difference through compliance excellence!

Job Type: Full-time

Pay: $68,000.00-$100,000.00 per year

Benefits:

  • Company events
  • Dental care
  • Disability insurance
  • Extended health care
  • Life insurance
  • On-site gym
  • On-site parking
  • Paid time off
  • Vision care

Education:

  • Bachelor's Degree (preferred)

Experience:

  • Regulatory Affairs: 2 years (preferred)

Work Location: In person

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