As a Medical Device Compliance Specialist, you will play a critical role in helping departments across the company, some that are new to compliance, to develop and implement the processes they need to ensure all our software solutions comply with regulatory requirements, standards, and guidelines related to medical device software as applicable. You will serve as a subject matter expert on software medical device compliance, consulting with teams on the review, assessment, and resolution of issues relating to all aspects of the Software Development Lifecycle. You will prepare regulatory submissions and updates to Risk & Compliance and product leadership on new and changed regulations affecting InterSystems products from a software medical device perspective.This role is a key member of the Risk & Compliance service and supports the Clinical Risk & Compliance leaders' oversight of the medical device software requirements to inform the overall compliance strategy. Reporting to the Clinical Risk & Compliance Manager, you assist the Clinical Risk & Compliance Team with its responsibilities in maintaining the medical device quality management system for InterSystems. In this role, you act as the bridge between technical knowledge and understanding of the software medical device standards and regulations and the applied experience and know-how of healthcare software and solutions. This requires an experienced individual who can effectively translate complex requirements into understandable guidance for teams and services and who can convince and influence those as to the benefits and need for a regulatory approach.There are two roles within the team, one based in Boston and one in the Windsor/Edinburgh. Both will work together to ensure the global requirements are met, and appropriate support is provided to product teams.Role Responsibilities
- Consult with departments, some new to compliance, educating, influencing, supporting, and helping them so they can meet their compliance goals.
- Maintain current levels of knowledge on the relevant certifications (ISO 13485/MDR)
- Collaborate with cross-functional teams to effectively and creatively integrate compliance considerations into everyday processes.
- Support development and delivery of ongoing education and awareness for InterSystems staff in software medical device compliance as part of the overall compliance strategy with an engaging approach.
- Work as part of the Clinical Risk & Compliance Team to support and enhance the development and maintenance of regulatory compliance strategies for our medical device software products.
- Contribute significantly to the maintenance and ongoing development of the InterSystems Medical Device Quality Management System.
- Ensure that all relevant InterSystems software products are assessed for relevant regulatory compliance.
- Monitor and track changes in regulations and standards that may impact our software products and processes, providing reports and updates to the Clinical Risk & Compliance Manager.
- Manage and cultivate relationships with external consultants and advisors as well as internal stakeholders, department heads, and leaders to support compliance activities.
- Lead and participate in internal audits and assessments to ensure compliance with relevant regulations and standards, identifying potential gaps and opportunities for improvements and collaborating on strategies to address these.
- Liaise with regulatory agencies and notified bodies as necessary to ensure timely and successful product registrations and submissions.
- Where required, assume the role of Person Responsible for Regulatory Compliance in support of Medical Device Registrations.
Required Skills and Experience
- Bachelor's degree in a relevant field, e.g., Bio-engineering, Life Sciences, Regulatory Affairs, or related discipline. Master's degree preferred.
- Minimum of 5-years' experience in medical device compliance, with expertise and demonstrable experience in medical device software compliance.
- Strong knowledge of global medical device regulations, such as FDA, EU MDR, ISO 13485, ISO 14971, IEC 62304, DCB, and other relevant standards.
- Prior experience interacting with regulatory agencies and notified bodies.
- Excellent communication, interpersonal and research skills with a proven ability to translate complex issues such as legal and regulatory requirements into an easy to understand ask of the business.
- Ability to engage people in compliance in a meaningful way, with a willingness to work to find solutions that meet requirements in the most effective way.
- Ability to work independently and collaboratively in a fast-paced environment with cross-functional teams and external partners.
- Detail-oriented with a strong commitment to quality and compliance.
We are an equal-opportunity employer and do not discriminate because of race, color, religion, sex, national origin, ancestry, marital status, veteran status, age, disability, sexual orientation or gender identity or expression or any other legally protected category. InterSystems is an E-Verify Employer in the United States.About InterSystemsEstablished in 1978, InterSystems provides innovative data solutions for organizations with critical information needs in the healthcare, finance, and logistics sectors and beyond. Our cloud-first data platforms solve interoperability, speed, and scalability problems for organizations around the globe. InterSystems also develops and supports data management in hospitals through the world's most proven electronic medical record, as well as unified care records for health systems and governments through a powerful suite of healthcare data integration solutions. The company is committed to excellence through its award-winning, 247 support for customers and partners in more than 80 countries. Privately held and headquartered in Cambridge, Massachusetts, InterSystems has 25 offices worldwide. For more information, please visit InterSystems.com.