In this role, you will be responsible for regulatory affairs activities including customer complaints
handling, assure compliance with applicable medical device regulations per jurisdiction, guidance, and standards. In addition, assist in creation, and maintenance of regulatory files, assist in regulatory submission, annual reports, registrations, and listings.
Manage the overall customer complaints activities in the company, including:
Investigates & customer complaints according to applicable regulatory requirements.
Ensures timely investigation of and response to product complaints. This involves initiating and participating in investigations and corrective action arising from product complaints.
handling, assure compliance with applicable medical device regulations per jurisdiction, guidance, and standards. In addition, assist in creation, and maintenance of regulatory files, assist in regulatory submission, annual reports, registrations, and listings.
Manage the overall customer complaints activities in the company, including:
Investigates & customer complaints according to applicable regulatory requirements.
Ensures timely investigation of and response to product complaints. This involves initiating and participating in investigations and corrective action arising from product complaints.
Requirements:
Relevant degree (e.g., biomedical engineering or related science / technical discipline)
Related experience in similar position in a medical device manufacturing company
Experience and knowledge with standards and regulations (MDR 2017/745, ISO 13485, FDA QSR)
Experience with managing customer complaints, risk analysis
Excellent English language skills (verbal and writing)
Relevant degree (e.g., biomedical engineering or related science / technical discipline)
Related experience in similar position in a medical device manufacturing company
Experience and knowledge with standards and regulations (MDR 2017/745, ISO 13485, FDA QSR)
Experience with managing customer complaints, risk analysis
Excellent English language skills (verbal and writing)
This position is open to all candidates.
