Sr. Quality

Job description

Job Location: Pune

IZiel Healthcare is an Engineering & Regulatory service provider working with global medical device manufacturing. We partner with customers to support them for all aspects of medical device Product Development Life Cycle.

Employees are the key to success in our organization. We value our engineers and their skills in furthering the cause of helping lives. Thorough leadership, robust work planning methodology and exceptional customer service are the key enablers of our success.

POSITION DESCRIPTION:

Senior Quality and Regulatory Affairs (QARA) Specialist will provide leadership in the quality and regulatory functions to understand regulatory requirements of medical devices, create relevant documentation and providing consultancy as an expert in regulatory affairs for IZiel clients. Senior QARA Specialist would work with global medical device manufacturers to get CE / USFDA approvals enabling product launch/sale in Europe and/or USA. The candidate would also work in developing QMS Documentation, Clinical Evaluation Plan & Report and would undergo extensive on-the-job training for various country specific regulations as needed. The candidate must keep themselves up-to-date with the latest and greatest developments as well as represent IZiel at various forums from time to time. QARA Specialist shall support IZiel clients to comply with the new Medical Device Regulation (MDR) for CE Approval.

POSITION RESPONSIBILITIES:

• Senior QARA Specialist would work with IZiel Team & Customer to successfully complete all deliverables within time and budget.
• Co-ordinate with IZiel customer to understand their requirements, prioritize the tasks & ensure deliverables are met as per customer needs.
• Work with global IZiel Team to execute the project with an Onshore – Offshore Model.
• Candidate must possess extensive knowledge of regulatory pathways for medical devices approvals in various countries with primary focus on US & European regulatory pathways.
• Candidate would research data and develop a regulatory strategy for approval.
• Candidate would develop regulatory strategy for the customer and would create documents as per the strategy.
• Candidate would compile the Technical File/Design Dossier as per USFDA and CE guidelines.
• Candidate would write the 510(k) and PMA applications with relevant information and input from the engineers.
• Candidate would work on USFDA Submissions, Establishment Registration & Device Listing.
• Strong and in-depth understanding of cGMP regulations per 21 CFR and ISO Understanding of Risk Management per ISO14971.
• Candidate would conduct Literature Search & develop CEP/CER as per new MEDDEV Regulations.
• Perform audit compliances, analyze gaps, shortcomings as per FDA/ISO regulations.
• File Annual Reports and manage regulatory changes per FDA and/or CE Guidelines.
• Regular participation in meetings with global IZiel Team to communicate priorities, customer requirements and ensure deliverables are completely understood and set clear expectations.
• Conduct Quality Check on deliverables from the QARA Team prior to submitting to the customer.
• Resolve queries, customer concerns & drive the project to completion
• Develop & present project plan, key issues/ risks to the customers.
• Maintain current working knowledge of the key international standards, regulations and regulatory guidance that govern the medical devices industry, medical electrical equipment.
• Develop long-term relationship with existing customers & ensure customer satisfaction.

DESIRED/PREFERRED QUALIFICATIONS:

• 7+ years experience in QARA Projects for medical device companies
• Team Player with strong execution abilities to complete projects within timeline with
• Strong & Clear Communication, Presentation & Coordination Skills (Written & Oral)
• Ability to coordinate with customer, manage requirements and successfully complete deliverables.
• Attention to detail with task prioritization capabilities (Tactical, Operational & Strategic)
• Working understanding of FDA, GMP and ISO 13485.
• Willingness to travel
• Bachelor Degree or any Advanced Engineering Degree