Lead Engineer

Job Responsibilities

• Continuously monitor changes in industry standards, regulations, and compliance requirements relevant to the company's products and operations. Stay informed about emerging trends and best practices in compliance.
• Develop and implement strategies, policies, and procedures to ensure the company's products and operations align with industry standards and regulatory requirements. Work closely with cross-functional teams to integrate compliance practices into product development, manufacturing processes, and quality control.
• Collaborate with commercialization teams, clinical study team and other relevant stakeholders to address compliance requirements at every stage of the product lifecycle. Guide and provide expertise to ensure compliance from design to manufacturing to distribution.
• Serve as the main point of contact for prototype/product development for all Centre’s commercialization projects and engage in regular communication and reporting as required.
• Conduct training sessions and workshops for employees on prototype/ product development
• Keep abreast of emerging regulations and industry trends related to product development. Proactively assess the impact of these changes on the company's operations and develop strategies to comply with new requirements.

Job Requirements

• Master’s or Bachelor's degree in Engineering or a related field. Advanced degree preferred.
• At least 5 years of experience in a product technical development, showing relevant experience on regulatory compliance in medical devices is preferred.
• Proven experience and in-depth knowledge of updated relevant industry standards, regulations, and guidelines.
• Strong leadership skills with the ability to effectively manage a team and drive projects to completion.
• Excellent analytical, problem-solving, and decision-making abilities.
• Exceptional communication and interpersonal skills.
• Attention to detail and a high level of accuracy.
• Ability to adapt to changing regulations and work effectively in a fast-paced environment.