Medical Device Compliance Engineer
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Job Location:
Monthly Salary:
Posted on:
12 hours ago
Vacancies:
1 Vacancy
Job Summary
Company: Willware Technologies
Role: Medical Device Compliance Engineer
Experience: 7 Years
Location: Bangalore
Work Mode: Onsite
Job Summary
We are looking for an experienced Medical Device Standards Compliance Engineer to ensure that medical devices meet international safety and regulatory requirements. The candidate will be responsible for managing product compliance with global standards coordinating with external certification laboratories and preparing regulatory documentation for product approvals.
Key Responsibilities
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Lead compliance activities related to IEC 60601-1 and related collateral standards for medical devices.
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Work closely with external safety testing labs and notified bodies such as UL TÜV ETL DQS and LNE to obtain product approvals and certifications.
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Ensure products comply with European Union Medical Device Regulation requirements.
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Prepare and maintain regulatory documentation including Technical Files STED and GSPR for CE marking.
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Support the product development team by providing compliance guidance during design and development phases.
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Coordinate testing activities and resolve compliance issues identified during certification testing.
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Maintain accurate documentation for regulatory submissions and product approvals.
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Stay updated with changes in medical device regulations standards and certification requirements.
Required Qualifications
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Bachelors or Masters degree in Biomedical Engineering Electrical Engineering Electronics Engineering or related field.
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Minimum 7 years of experience in medical device standards compliance or regulatory engineering.
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Strong knowledge of IEC 60601 standards and medical device safety requirements.
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Hands-on experience with EU MDR and CE marking process.
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Experience working with notified bodies and external certification laboratories.
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Experience preparing technical documentation for regulatory approvals.
Required Skills:
IEC 60601-1EU MDRUVTÜVETLSTEDCE Marking
Key Skills
- Abinitio
- Apprentice
- Dermatology
- Cost Estimation
- Data Networking
- Liaison
