KEY RESPONSIBILITIES:

• Incumbent will be overall responsible for compliance as per MDD 93/42/EEC as amended by 2007/47/EC, ISO 13485:2016, ISO 9001: 2015, DCGI, Suppliers audit from several countries as per their local regulatory directives.
• Incumbent will be actively engaged in transition from MDD to EU MDR of CE marked Drug Eluting Stents and will be responsible for adherence to the deadline.
• Ability to take strategic direction and establish efficient and compliant processes throughout the organization and should have requisite communication and interpersonal skills to get them implemented.
• Head Regulatory Affairs and lead RA team.
• Develop, administer and maintain quality assurance procedures and activities required to ensure that the company's processes and products arein compliance to above mentioned directives
• Employ quality assurance methodologies in support of engineering, manufacturing and regulatory functions.
• Develop and implement quality control and inspection procedures for receipt and control of incoming materials, in-process materials and final product acceptance activities.
• Define quality control standards and test; specify test equipment and procedures.
• Coordinate and steer monthly product quality meetings.
• Establish and maintain test instrument calibration procedures and maintenance schedules.
• Establish quality assurance, quality control inspection and testing procedures.
• Identify quality assurance metrics; analyze and report trends to management.
• Review and responsible to withdraw non-conforming products and stop or released deliveries/shipments.
• Active participant in all stages of design development, testing and design control activities, ensuring quality assurance considerations and requirements met.
• Responsible for developing and maintaining sterilization validation and material biocompatibility activities.
• Should exhibit the ability to evaluate requirements for testability, design efficient test cases, and write extensive technical documentation.
• Participate in the review of product requirements, design requirements, software requirements specifications, and functional specifications.
• Assist in Risk Management activities and ensure compliance to standards and regulations.
• Assist in the failure investigation, product complaints and lead corrective and preventive actions.
• Manage and steer the Quality Control team to ensure full compliance towards the Quality Management System, processes and procedures and alignment.

REQUISITE SKILLS:

• Experience: 7+ years in class III Medical Device, preferably from vascular stents, ortho implants industry.
• Indian FDA, US FDA, RA, QA, QMS, GMP.
• Expert in MDD and upcoming EU MDR.
• Team Building
• Excellent communication skills
• Strong organizational skills with a problem-solving attitude