Job Summary
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:
Regulatory Officer ensures that a company’s products and operations comply with all relevant regulations and quality standards. This involves monitoring regulatory developments and changes, developing and implementing regulatory strategies, preparing and submitting regulatory applications and reports, and coordinating with cross-functional teams to ensure regulatory compliance is incorporated into product development and sales plans.
Role and Responsibilities:
The Regulatory Officer is responsible for ensuring that a company’s products and operations comply with relevant regulations and standards.
- Implementing and monitoring ISO-13485 quality agenda for the organization.
- Developing and implementing regulatory strategies that help the company to comply with all applicable regulations while maximizing the company's commercial opportunities.
- Preparing and submitting regulatory applications, notifications, and reports to regulatory authorities, such as the FDA, CE, Health Canada, and national regulatory bodies.
- Coordinating with cross-functional teams, such as R&D, Quality, and Manufacturing, to ensure that regulatory requirements are incorporated into product development plans and processes.
- Providing regulatory guidance and support to other departments, including Sales, Marketing, and Legal, to ensure that all promotional materials and communications comply with regulatory requirements.
- Maintaining accurate and up-to-date regulatory documentation and records.
- Managing relationships with regulatory authorities and third-party vendors, such as testing laboratories and consultants.
- Conducting internal audits to ensure compliance with regulatory requirements and identifying areas for improvement.
Required Skills
Skills and Qualification:
- B.E or BS degree required in Biomedical and Electronics fields.
- 1 – 2 years’ experience working in regulatory and quality management for Medical devices.