Regulatory Compliance Specialist
4 weeks ago
Job Summary
We are seeking a highly skilled Regulatory Compliance Specialist to join our team at InterSystems. As a key member of our Risk & Compliance service, you will play a critical role in helping departments across the company develop and implement processes to ensure our software solutions comply with regulatory requirements, standards, and guidelines related to medical device software.
Key Responsibilities
- Consult with departments to educate and support them in meeting their compliance goals.
- Maintain current levels of knowledge on relevant certifications, such as ISO and MDR.
- Collaborate with cross-functional teams to integrate compliance considerations into everyday processes.
- Support the development and delivery of ongoing education and awareness for InterSystems staff in software medical device compliance.
- Work with the Clinical Risk & Compliance Team to support and enhance the development and maintenance of regulatory compliance strategies for our medical device software products.
- Contribute to the maintenance and ongoing development of the InterSystems Medical Device Quality Management System.
- Ensure all relevant InterSystems software products are assessed for regulatory compliance.
- Monitor and track changes in regulations and standards that may impact our software products and processes.
Requirements
- Bachelor's degree in a relevant field, such as Bio-engineering, Life Sciences, or Regulatory Affairs.
- Minimum of 5 years' experience in medical device compliance, with expertise in medical device software compliance.
- Strong knowledge of global medical device regulations, such as FDA, EU MDR, and ISO.
- Prior experience interacting with regulatory agencies and notified bodies.
- Excellent communication, interpersonal, and research skills.
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