Deck Mount Electronics
Website:
deckmount.in
Job details:
Reporting To: COO / Plant Head
Department: Quality & Compliance
Job Purpose
To ensure full compliance of the medical devices manufacturing unit with Indian regulatory, statutory, and quality requirements, particularly under the Medical Device Rules (MDR), 2017, and to support regulatory inspections, audits, and continuous compliance across operations.
KRAs
1. Regulatory Compliance
· Ensure compliance with:
o Medical Device Rules (MDR), 2017
o Requirements of Central Drugs Standard Control Organization (CDSCO)
o State Licensing Authority (SLA), as applicable
· Ensure valid manufacturing licenses, product permissions, and timely renewals.
· Coordinate regulatory submissions, variations, and amendments with CDSCO/SLA.
· Act as the single point of contact during regulatory inspections and audits.
2. Quality Management System (QMS) Compliance
· Support implementation and maintenance of:
o ISO 13485:2016
o Schedule V requirements under MDR, 2017
· Ensure adherence to Good Manufacturing Practices (GMP) as applicable to medical devices.
· Participate in internal audits, regulatory audits, and third-party audits.
· Track non-conformities, CAPAs, and ensure timely closure.
3. Documentation & Record Control
· Ensure accurate maintenance of:
o Device Master Files (DMF)
o Plant Master Files (PMF)
o SOPs, records, logs, and registers
· Review compliance-related documentation for accuracy and regulatory alignment.
· Ensure document control and record retention as per MDR requirements.
4. Vigilance, Complaints & Recalls
· Support compliance with Materiovigilance Programme of India (MvPI).
· Coordinate reporting of adverse events and field safety corrective actions, if any.
· Assist in investigations related to product complaints, deviations, and recalls.
· Ensure regulatory reporting timelines are met.
5. Risk & Compliance Monitoring
· Identify regulatory and compliance risks across manufacturing, labeling, storage, and distribution.
· Monitor regulatory updates, gazette notifications, and CDSCO circulars.
· Assess impact of regulatory changes and support implementation.
6. Training & Compliance Culture
· Conduct periodic training on:
o MDR, 2017
o GMP and QMS requirements
o Regulatory inspection preparedness
· Ensure training effectiveness and maintenance of training records.
· Promote a culture of regulatory compliance and ethical practices.
7. Cross-Functional Coordination
· Work closely with:
o Quality Assurance
o Production
o Warehouse & Supply Chain
o Engineering & Maintenance
· Support new product registrations and scale-up activities from a compliance standpoint.
Key Skills & Competencies
· Strong working knowledge of Medical Device Rules, 2017
· Familiarity with CDSCO processes and inspections
· Understanding of ISO 13485 and Schedule V
· Documentation and audit-handling capability
· Strong attention to detail and regulatory interpretation skills
· High ethical standards and compliance mindset
Qualifications
· Bachelor’s degree in:
o Biomedical / Mechanical / Electrical / Electronics Engineering
o Pharmacy
o Life Sciences
· Certification or diploma in Regulatory Affairs / Quality / Compliance preferred.
Experience
· 5–7 years of experience in:
o Medical devices manufacturing (Preferred)
o Regulatory compliance / Quality systems
· Hands-on experience with CDSCO or SLA inspections is mandatory
Click on Apply to know more.