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LivaNova Looking for Regulatory Affairs and Quality System Manager

 

Clinical courses

More than 1 million patients in 100 countries are helped by our products every year thanks to our employees and their dedication to researching, developing and manufacturing cutting-edge technology for the treatment of cardiovascular diseases.  Their commitment has made our company a major player in managing cardiac rhythm management and heart failure and the world leader in cardiac surgery – a world leader proud of its business ethics – a value we live by

Post : Regulatory Affairs and Quality System Manager India (M/F)

Job Description
The Regulatory Affairs and Quality System Manager will implement and maintain appropriate Quality Management System controls at LivaNova India in alignment with the Company Quality Management System and local regulatory requirements. He/she will coordinate and manage regulatory submissions and approvals to commercialize the Medical Devices manufactured and distributed by the Company in India. He or she will act as Qualified Person in India for the marketing of Company products. Additionally, he or she will provide quality and regulatory expertise and direction to supply chain, sales and marketing and distribution partners regarding label content for all registered products in India. This position will communicate with department members, government agencies and a host of individuals outside the company in a professional, decisive, and articulate manner.

Essential Functions:  

  • Manage Pre Marketing Approval, license maintenance and renewal activity in India, either directly or through the local distributors and in conjunction with global Regulatory Affairs
  • Prepare the technical and formal documentation necessary to obtain registrations in India, and keep them in compliance with product changes with particular focus on Indian Regulations
  • Cooperate in the relationships with Regulatory Authorities, Competent Authorities and the National Government Agencies
  • Distribute appropriate notifications for product approvals and report on the status of approvals to global Regulatory Affairs
  • Implement and maintain Quality Management System requirements of Commercial LivaNova entities for LivaNova India and additional regional entities as needed
  • Monitor, verify and review product documentation (Instructions for use, brochures, Company website, etc) to ensure compliance with relevant law requirements
  • Interface/correspond with government agencies, industry organizations, distributors, and international personnel to keep abreast of quality system requirements
  • Provide necessary/requested information and materials to government agencies, distributors, and international personnel to meet quality system and regulatory requirements
  • Provide input to project development teams to ensure that appropriate regulatory strategies are communicated, and regulatory requirements are met
  • Assist if required during facility audits/assessments by government agencies
  • Keep updated a high level of knowledge and comprehension of laws and regulations impacting on Company products
  • Coordinate product complaint & adverse event reporting activity and report such events within stipulated time of becoming aware, per Company policy
  • Attend applicable training sessions as well as complete mandatory on-line trainings and work as per the applicable policies and guidelines
  • Follow Bio-Safety practices while handling complaint samples 
  • Report any evidence of product tampering, diversion and counterfeiting to the Brand Integrity function
  • Participate in execution of Field Action (Product Recall, Distribution of Field Safety Alerts, etc.) and complete the assigned tasks in a timely manner

Knowledge and Skills

  1. Knowledge of the relevant  laws and directives for placing on the market and commercialize the Medical Devices
  2. Ability and experience in preparation of technical and formal documentation necessary for submission and assessment at Notified Bodies and / or Competent Authorities.
  3. Ability and experience in implementing and maintaining a quality management system following e.g. ISO9001 or ISO13485
  4. Attitude to interpersonal relationship, to efficient communication, written and oral; projects management.
  5. Excellent verbal and written communication skills required, fluent in English
  6. Ability to work in a global matrix environment required  ·         Demonstrated understanding of Regulatory Affairs processes, both pre-  and post marketing is preferred.
  7. Broad based experience across various disciplines is preferred 
  8. Proven track record of demonstrating knowledge and understanding of compliance topics

Find more info on Next Page...

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Candidate Profile :
1). A current license in Pharmacy 
2). A Bachelor's degree in Pharmacy, science, or an advanced degree in a technical, medical or business area is an asset
3). A minimum of 5 - 6 years of successful experience in a regulated healthcare environment, medical device, pharmaceutical, biologics is required with knowledge of the relevant laws and   directives for placing on the market and commercialize the Medical Devices, including Quality System controls
4). Experience in preparing technical documentation to obtain product registration is preferred

Additional Information:
Experience: 5-6 years
Qualification: B.Pharm
Location: Delhi
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Regulatory Affairs
End Date: 29th Octocber, 2016

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