RA/QA Specialist at our client - a Medical Device Consultancy

Overview

We are seeking a detail-oriented and motivated RA/QA Specialist to join our client. The RA/QA Specialist will be responsible for ensuring regulatory compliance and quality assurance of medical devices. This individual will play a critical role in maintaining the highest standards of safety and efficacy for our products.

Responsibilities

Collaborate with cross-functional teams to ensure regulatory compliance and quality assurance of medical devices Develop and maintain regulatory submissions and technical documentation Support audits and inspections by regulatory agencies and notified bodies Implement and maintain quality management systems to ensure conformity with regulations and standards Conduct risk assessments and develop risk management plans Provide guidance and support on regulatory and quality requirements to internal teams Stay updated with changes in regulations and standards and ensure timely implementation within the organization

Qualifications

Bachelor's degree in a related scientific or engineering field Strong knowledge of medical device regulations such as FDA QSR, ISO 13485, MDR, and other global regulations Experience in preparing regulatory submissions and technical documentation Familiarity with quality management systems and regulatory standards Excellent communication and interpersonal skills Ability to work effectively in a team and independently Attention to detail and strong organizational skills

Day-to-day

As an RA/QA Specialist, you will collaborate with various teams to ensure compliance with regulatory requirements, develop and maintain regulatory submissions, and support audits and inspections. You will also be responsible for staying updated with changes in regulations and standards, providing regulatory guidance to internal teams, and implementing quality management systems to maintain conformity with regulations.

Benefits

Competitive salary Health and wellness benefits Opportunities for professional development and growth Collaborative and inclusive work environment Contribution to meaningful and impactful work in the healthcare industry