Essential Duties and Responsibilities:
· Responsible for the management the Quality Management System.
· Responsible to achieve and maintain ISO 13485, MDSAP, MDR and other required Quality Management System regulations
· Fulfill the role of Management Representative
· Responsible for product conformance to applicable standrards and regulatory requirements.
· Responsible for product registration and listing with regulatory authorities
· Responsible for final decisions related to products’ conformance and release.
· Responsible for Quality Control testing.
· Responsible for approval of design and manufacturing changes and determination of their regulatory submission requirements.
· Has Sign-off authority for changes to procedures, processes, designs etc.
Qualifications:
· Thorough knowledge of regulatory requirements pertaining to FDA/QSR, ISO 13485, MDSAP, MDR and other markets requirements
· Effectively prepare, represent and communicate with Regulatory Agencies during audits.
· Strong interpersonal, communication, writing, and organizational skills required to effectively work in a quality/regulatory and project team environment. Detail oriented.
· Strong analytical and mathematical skills are required to interpret and analyze scientific test data for quality systems functions and regulatory submissions.
· Strong leadership and program management experience.
· Good computer skills (Word processing, spreadsheets, graphics, internet).
Education and/or Experience:
· Bachelor’s degree (preferably in engineering)
· Not less than 10 years’ experience in the Medical Device / Pharmaceutical Industry Quality Assurance and regulatory affairs
