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Quality/Regulatory Manager - Medical Device
Turn a software organization to medical device regulations
ISO 13485 and FDA experience
About Our Client
Our client is a well established international software company near Cambridge, MA. They are currently looking to hire a Quality/Regulatory Manager - Medical Device with experience in ISO 13485 and EU regulations. This person would work within the legal department and be the champion for taking a software organization to Medical Device regulations.
- Designing and presenting appropriate, risk-based medical device compliance programs for management approval
- Day-to-day monitoring and reporting of medical device compliance risks
- Coordinating and maintaining the certification for medical device products
- Develop procedures for managing subcontrators and vendors to ensure medical device compliance
- Design and recommend tools for managing compliance records and workflows related to medical device compliance
- Assist product teams with clinical risk assessment and management.
The Successful Applicant
- 8+ years of hands-on experience with regulatory compliance, preferably including medical device compliance for software products
- Hands-on experience with ISO 13485 required.
- Ability to travel up to 25% internationally
- Excellent written and verbal communication
What's on Offer
- Lead a company from software to medical device
- High influence position
- Excellent benefits and compensation package