Employer Industry: Medical Device Testing and Certification

Why Consider this Job Opportunity:
- Salary up to $178,000 annually (based on market location and experience)
- Competitive benefits package including health care, retirement benefits, paid time off, and wellness programs
- Opportunity for growth and development through internal training and education assistance programs
- Remote work model, allowing for flexibility and work-life balance
- Chance to work with a global organization and make a positive impact on safety and sustainability outcomes
- Collaborative and professional work environment

What to Expect (Job Responsibilities):
- Access and review client's medical device files for regulatory requirements in European markets
- Apply knowledge of regulatory requirements to manufacturers' processes and products
- Conduct audits of manufacturers to ensure compliance to various medical device regulations
- Review product design, document deficiencies, and review engineering and manufacturing processes
- Create reports for clients using analytical and communication skills

What is Required (Qualifications):
- Minimum 4-year degree in Engineering, Biomedical, Medicine, Pharmacy, Biology, Biotechnology, Clinical Physics, or related discipline
- 7-10 years of experience in a similar role in the Medical Device field or Notified/Accreditation Body Industry
- Strong background in design engineering or R&D
- Knowledge of global regulatory affairs and CE Medical Device Directives
- Experience with MDD, AIMD, IVD, MDR, IVDR
- Excellent interpersonal, verbal, written, and presentation skills

How to Stand Out (Preferred Qualifications):
- MS degree or PhD in a related field
- Familiarity with ISO 13485 and MDSAP
- Broad knowledge of medical devices and engineering applications

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