Manager – Regulatory Affairs

  Regulatory Affairs

Job title: Manager – Regulatory Affairs

Company: Antal International

Job description:

  • 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

© 2022: Antal International

Antal International operates as both an Employment Agency & an Employment Business under laws applicable to Executive Search & Selection Firms, Recruitment Consultants & Recruitment Agencies in the UK, Europe & Asia. UK Registered Number 06020652

Expected salary:

Location: Dehradun, Uttarakhand

Job date: Thu, 25 Aug 2022 22:59:49 GMT

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