Quality Assurance And Regulatory Affairs Specialist

Job Title: Quality Assurance and Regulatory Affairs Specialist 

Location: Cambridge (2-3 days per week onsite)

About: 

A distinguished medical device company based in Cambridge, dedicated to pioneering innovative healthcare solutions is seeking a highly skilled and motivated individual to join its team as a Quality Assurance and Regulatory Affairs Specialist. The successful candidate will play a pivotal role in ensuring that the company's products align with regulatory requirements and maintain the highest standards of quality.  

Responsibilities: 

Regulatory Compliance: Ensure alignment of products with local and international regulatory requirements. 

Quality Management: Implement and sustain effective quality management systems to uphold product quality standards. 

Documentation: Prepare and submit precise and comprehensive regulatory documents. 

Audits and Inspections: Coordinate and actively participate in internal and external audits, including regulatory agency inspections. 

Risk Management: Conduct thorough risk assessments and devise strategies to mitigate potential quality and Regulatory risks. 

Cross-Functional Collaboration: Collaborate with cross-functional teams to support product development, manufacturing, and post-market surveillance activities. 

Requirements: 

Bachelor's degree in a relevant scientific Quality Assurance or engineering discipline. 

Minimum of 3 years of experience in Quality Assurance and/or Regulatory Affairs  

Knowledge of regulatory requirements for medical devices (ISO 13485, FDA, MDSAP etc.). 

Strong comprehension of quality management systems and practices. 

Excellent communication and interpersonal skills. 

Proven ability to work collaboratively in a fast-paced and dynamic environment.