Electronic Device History Record Specialist

3 days ago


Noida, Uttar Pradesh, India beBeeCompliance Full time
Senior Compliance Specialist

This role is responsible for defining the vision, roadmap, and compliance-focused features for Electronic Device History Record (EDHR) platforms. The ideal candidate will have a strong understanding of regulatory frameworks such as 21 CFR Part 820, EU MDR, and ISO.

  1. Translate regulatory frameworks into digital product specifications.
  2. Lead integration of EDHR with MES, PLM, and QMS systems in medical device manufacturing environments.
  3. Support technical pre-sales, audits, and validations to ensure adherence to regulatory standards.
Key Responsibilities
  1. Act as Subject Matter Expert (SME) for global medical device manufacturing compliance (DHF, DHR, MDR).
  2. Prioritize and manage product backlog aligned with regulatory demands and business value.
  3. Engage with cross-functional teams to ensure agile delivery of validated digital solutions.
  4. Drive continuous improvement and regulatory readiness through digital transformation initiatives.

The successful candidate will be an expert in their field, able to interpret complex regulatory requirements and translate them into actionable plans. If you are looking for a challenging role that requires strategic thinking and technical expertise, this may be the opportunity for you.



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