Medical Device Specialist
4 days ago
We are seeking an experienced Medical Device Specialist to join our team in Ahmedabad, India. This is a full-time opportunity that offers a competitive salary and excellent benefits package.
As a Medical Device Specialist, you will be responsible for planning and conducting audits/assessments in accordance with ISO 13485, EU MDR, and MDSAP standards.
You will work closely with our team of auditors to ensure effective customer relationships and deliver high-quality services. Your key responsibilities will include:
- Conducting audits (desk-based or on-site) in accordance with established procedures.
- Reviewing technical files specific to medical devices being authorized.
- Completing all chargeable work within budget and timeframes to ensure customer satisfaction.
- Project managing auditing teams to maximize efficiencies and enhance client satisfaction.
To be considered for this role, you will require at least 10 years of professional experience in a relevant field, such as healthcare products or quality management. You should also have a strong knowledge of medical device management systems, standards, and auditing techniques.
Required Skills and QualificationsThe ideal candidate will possess the following skills and qualifications:
- Excellent working knowledge of medical device management systems, standards, and auditing techniques.
- Good knowledge of ISO 13485, MDD 93/42/EEC, and Indian Medical Device Regulations.
- Experience working with recognized standards, including MDR 2017/745 and MDSAP.
- Solid knowledge of non-active devices and sterilization processes.
- Registered IRCA lead auditor or equivalent registration under another recognized body.
We offer a range of benefits, including flexible work arrangements, paid leaves, medical benefits, pension and insurance policies, training and development assistance, and additional benefits.
About UsLifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talented professionals with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.
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