Medical Device Compliance Specialist
2 days ago
Medtronic is a leader in medical technology, offering innovative solutions for patients and healthcare professionals. We are seeking a highly skilled individual to join our team as a Medical Device Compliance Specialist.
Estimated Salary: $80,000 - $110,000 per year
Job Description:
As a Medical Device Compliance Specialist, you will play a critical role in ensuring that our medical devices meet the highest standards of quality and safety. Your responsibilities will include:
- Reviewing and evaluating product complaints to identify potential issues with device performance or safety;
- Evaluating complaint information and determining whether it meets reporting criteria for government agencies;
- Writing investigation summaries based on technical product analysis information provided by our plant;
- Liaising with internal teams, including Technical Services, Manufacturing, R&D, and Quality Assurance, to resolve complaint-related issues;
- Providing technical expertise and assistance in handling complaints to comply with FDA and international regulations;
- Interpreting risk management documentation related to complaint events;
- Collaborating with external stakeholders, including customers, vendors, and healthcare professionals.
Required Skills and Qualifications:
To be successful in this role, you will need:
- A Bachelor's degree in Engineering or a Science discipline, such as Biomedical Engineering;
- 4-8 years of experience in quality assurance or regulatory affairs within the medical or pharmaceutical industry;
- Strong typing skills and ability to write business documents with minimal supervision;
- Excellent verbal and written communication skills, with the ability to work effectively in a team-oriented environment;
- Ability to multitask and prioritize multiple projects simultaneously;
- Strong analytical and problem-solving skills, with the ability to interpret complex data and make informed decisions.
Benefits:
We offer a competitive compensation package, including a base salary, bonuses, and comprehensive benefits. You will also have opportunities for professional growth and development within a dynamic and innovative organization.
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