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Director, Quality and Regulatory Affairs

Director, Quality and Regulatory Affairs

GetingeRepublic Of India, IN
30+ days ago
Job description

Job Overview :

The Director of QRC, IN will serve as an active member of the Global Sales (GS) SAPAC region QRC leadership and IN SSU Leadership Teams, on top of the role as IN SSU Management Representative. He / She will provide Regulatory & Quality Leadership for the IN SSU where Getinge is present. The incumbent is expected to have good understanding of the IN country’s QA & RA requirements and is also expected to lead activities to bridge gaps in the QMS & product registration requirements. Managing and insuring proper filing of all required compliance documents, submissions, registrations, etc to ensuring products supplied in India meet the requirements of the Medical Devices Rules 2017.

This role will have a solid line reporting to Senior QRC Director, APAC & dotted reporting to the Managing Director, IN SSU.

Job Responsibilities and Essential Duties :

  • A list of the main responsibilities and percentage of time spent in each responsibility or group of responsibilities :
  • (30%) Execute the job responsibilities according to applicable Global Sales Quality Management System (GS QMS), Local Quality Management System of India, and other requirements
  • (30%) Ensure Post Market Vigilance activities are executed on a timely manner according with local and Getinge Corporate requirements
  • (25%) People Leadership
  • (15%) Product Registration on a timely & compliance manner

Strategic Planning

  • Develop and implement local Quality Systems in line with Global Sales QMS
  • Development and implementation of the QRC strategic plan.

    • Required Knowledge, Skills and Abilities

  • Strong leadership and communication skills
  • Resourceful and independent team player
  • Mature, pro-active working attitude and able to work under pressure.
  • A team player and a self-starter with strong inter-personal and presentation skills

    • Supervision / Management of Others

  • Responsible for the development and management of QRC manager and specialist and programs for the team and retain high potential employee
  • Provide clear direction and keep the work group moving forward and focused on the right

    • Internal and External Contacts / Relationships

  • Main contacts, internal

    • o Management team

    o QRC team in region

    o BA QRC teams

    o Sales department

    o Service department

    o Logistics department

  • Main contacts, external

    • o Central Drugs Standard Control Organization, Ministry of Health & Family Welfare

  • Other agencies such as Bureau of Indian Standards

    • o ISO certification body (TUV SUD Europe)

    o Distributors

    Environmental / Safety / Physical Work Conditions

  • Ensures environmental consciousness and safe practices are exhibited in decisions.
  • Use of computer / laptop and telephone equipment and other related office accessories / devices to complete assignments
  • May work extended hours during peak business cycles & desk bound e.G. ISO certification audit & preparation of product registration documents for submission.
  • Physical requirements : requires carrying of laptop and its associated accessories during travelling.
  • Travel requirements : requires occasional interstate travel and international travel

    • Minimum Requirements :

  • Bachelor’s degree in engineering or Life Science related field or equivalent.
  • A minimum of 10 years hands-on experience in Quality Assurance, preferably in a medical device company.
  • Able to work ground up to build the quality system in the R&D organization to match and surpass global requirements and customer expectations.
  • Startup mindset, where person should be able to work on the ground at the initial phase while working on the future development of the quality organization. Experience similar to this will be an added advantage.
  • Progressive leadership experience including hands on advanced quality system strategy.
  • Excellent knowledge of FDA and EU regulatory compliance for medical devices.
  • Demonstrated knowledge of Quality System Regulation (QSR) and Quality System Inspection Technique Audits (QSIT).
  • Strong influencing skills and the ability to build strong interpersonal relationships.
  • Excellent communication skills including public speaking and strong written skills.
  • Demonstrated leadership in a cross-functional environment.
  • Advanced skills in MS Office applications (Word / Excel) are required.
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    Director Quality Regulatory • Republic Of India, IN

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