Senior Manager (Quality & Regulatory Affairs)

Role & responsibilities

• Build the

  QMS end to end to ISO 13485:2016

  : perform gap analysis, draft SOPs/WIs, deploy training, run Stage 1/2 audits and close nonconformities to achieve certification.
• Own Design Controls & Documentation: create/maintain

  SRS, DHF, DMR, Risk Management File (ISO 14971)

  , software lifecycle records (IEC 62304), trace matrices and labelling; ensure change control discipline.
• Regulatory Strategy & Submissions: chart and execute stepwise pathways

  CDSCO

  manufacturing licence & device registration first, then

  FDA 510(k) and EU MDR CE Mark

  ; prepare technical documentation/dossiers and coordinate with test labs, auditors and notified bodies.

• Audits, CAPA & Metrics:

  plan and conduct internal audits, lead CAPA investigations, track effectiveness, and publish quality KPIs (training status, NC/CAPA ageing, doc control health) to leadership.
• Supplier & Manufacturing Quality: qualify critical suppliers/CMOs; define IQ/OQ/PQ plans; establish incoming

  /in-process controls, traceability and batch-release evidence.

• Consumables & Sterilisation Readiness: support packaging validation and sterile barrier qualification (ISO 11607) and sterilisation modality alignment (EtO/Gamma) as relevant.
• Post Market & Vigilance: set up complaint handling,

  PMS/vigilance procedures

  and field action workflows aligned with India/US/EU expectations.

• Enable & Train Teams:

  interpret standards for engineers, run checklists and docs clinics, and raise the organisation's documentation quality.

• eQMS / Doc Control:

  implement pragmatic doc and record control and training record systems with audit trails.

Preferred candidate profile

• Bachelor's degree in Engineering/Life Sciences (Biomedical/Mechanical/Electronics or related). ISO 13485 internal auditor certification preferred (or willingness to obtain within 6 months).
• 4+ years of QARA experience on Class II+ medical devices, with hands-on ISO 13485 implementation and participation in at least one CDSCO dossier or a 510(k)/EU MDR Technical File.
• Working knowledge of ISO 14971, IEC 62304, IEC 60601 (awareness), IEC 623661 (usability), ISO 10993, ISO 11607, and Indian MDR 2017; familiarity with UDI concepts and eQMS workflows (doc control, training, CAPA).
• Excellent technical writing and the ability to translate regulatory language into clear, actionable guidance for engineers.
• Track record of operating with minimal supervision across multiple concurrent workstreams.