About this role
The Medical Regulatory Services team ensures patient safety while supporting timely market access for our clients' medical device products globally under a variety of certification schemes such as ISO 13485, INMETRO, UKCA, CE Marking and MDSAP.
This is a home-based role with a 50-75% travel requirement.
- University Degree in Engineering, Biomedical Engineering, Biochemistry, Health Sciences, or Physics from an accredited program.
- Minimum of 4 years experience in the medical device field including at least 2 years must be hands-on medical device design, manufacturing, testing or clinical evaluation experience.
- Knowledge of business processes and application of quality management standards.
- Good verbal and written communication skills and an eye for detail.
- Working knowledge of conformity standards in use in areas of expertise.
- Demonstrated ability to apply project-handling concepts in use in areas of expertise including application to complex, new, or unusual products.
- Working knowledge of industry issues, needs, and problems.
- Good public speaking and business development skill will be considered advantageous.
- Ability to travel 50-75% domestically and internationally.
- USA state issued driver's license without restrictions.
- Valid USA passport without restrictions.