Quality Assurance and Regulatory Affairs officer

Open Position

General Description:

About us:
Tech4Life Enterprises specializes in developing and commercializing innovative healthcare software and medical devices for the developing world. Our objective is to improve access to care by empowering the communities and frontline health providers through simple, relevant, and low-cost health solutions.

Job Description:

GENERAL PURPOSE:
The QA &RA officer is responsible for managing the quality program within the organization and ensuring products developed by Tech4Life Enterprises Canada are in compliance with all applicable regulations. The incumbent will work closely with the consultant for Regulatory affairs and the engineering teams for preparation of required documentation. The incumbent will also be responsible for developing and expanding productive relationships with key stakeholders including CE, FDA and Health Canada. This role will manage regulatory projects from beginning to end while ensuring alignment between regulatory requirements, business objectives and corporate values.

Principal Duties and Responsibilities:

Manage documentation related to Quality Assurance program.
Prepare and submit documentation for regulatory approvals.
Review proposed labeling for compliance with Regulatory requirements.
Provides country specific regulatory input to project teams and recommend local regulatory strategy for new products.
Communicate with regulatory and governmental agencies in collaboration with the Consultant.
Apply applicable regulations to business practices and provide regulatory input, advice and guidance to stakeholders including marketing, operations and sales team.
Life cycle maintenance including but not limited to review of proposed product changes for impact on regulatory status of the product and determine the appropriate regulatory reporting requirements.
Review and evaluate promotion and advertising material for compliance with regulations.
Support the assembly, distribution, storage, tracking and retrieval of information pertinent to regulatory and quality processes including product complaints, recalls, and internal and external audits.
Support post-market submissions in accordance with the expectations of regulatory affairs. Collaborate with Manufacturers to respond to regulatory requests as needed.
Support the renewal of licences in different jurisdictions.
Support with quality systems maintenance and lead various improvement activities including SOPs, cross-functional training, and internal audits.
In collaboration with the consultant, support regulatory inspections and corporate / third party audits.

Expected Areas of Competence:

Working knowledge of relevant regulations for Medical devices, including of the CE, FDA and Health Canada.
Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including with regulatory agencies, superiors and peers.
Excellent team collaboration and teamwork skills across cross-functional teams.
Strong attention to detail; project management skills, ability to multi-task and balance competing priorities.
Knowledge of overall business environment, the orthopaedic industry and the marketplace is an asset.
Ability to learn and stay abreast of regulations pertinent to medical devices, biologics and combination products as needed, based on functional area.
Ability to build relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels.
Strong writing, communication, and interpersonal skills.
Strong problem solving skills.
Effective negotiating skills.

Education/Experience Requirements:

Bachelor’s degree in science / engineering required; advanced science degree preferred.
Regulatory Affairs Certification or Post grad studies in areas related to Quality Assurance and Regulatory affairs.
A minimum of 1-2 years of experience in Regulatory Affairs, Engineering, Quality, or related field required.
A combination of education and experience may be considered.