Employer Industry: Medical Device Certification

Why consider this job opportunity:
- Salary up to $164,000 annually
- Competitive benefits package including health care, retirement, and paid time off
- Opportunities for career advancement, including the potential to become a Senior Project Manager
- Remote work model allowing flexibility in work location
- Supportive work environment focused on professional development and well-being

What to Expect (Job Responsibilities):
- Access and review client medical device files for regulatory compliance in European markets
- Conduct audits of manufacturers to ensure adherence to MDD, AIMD, IVD, MDR, IVDR standards
- Document product design deficiencies and review engineering and manufacturing processes
- Create detailed reports for clients based on audits and regulatory analysis
- Collaborate with external consultants and present findings to clients

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

How to Stand Out (Preferred Qualifications):
- MS degree or PhD in a related field
- Experience with ISO 13485 and MDSAP audits
- Familiarity with multiple regulatory standards including MDD, AIMD, IVD, MDR, IVDR
- Broad knowledge of engineering and technical applications in medical device development

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