As a Medical Device Compliance Manager, you will play a critical role in maintaining and enhancing the compliance approach to ensure all our products and processes comply with regulatory requirements, standards, and guidelines related to medical devices. You will be responsible for reviewing, assessing, and resolving issues relating to our device manufacture and implementation strategies.

The oversight of the compliance aspects of product development, implementation and support, regulatory submissions, and medical device quality management systems are managed by a global compliance team, and this role is a key stakeholder in that.

Role Responsibilities

• Support the development and maintenance of regulatory compliance strategies for our medical device software products.
• Ensure that all medical devices (including products that can be marketed as medical device) are assessed for relevant regulatory compliance.
• Provide guidance and support to product development teams on regulatory requirements and compliance best practices.
• Collaborate with cross-functional teams to integrate compliance considerations into product design and development processes.
• Liaise with regulatory agencies and notified bodies to ensure timely and successful product registrations and submissions.
• Monitor and track changes in regulations and standards that may impact our products and processes.
• Monitor and track changes in regulations and standards that may impact our products and processes.
• Manage relationships with external consultants and advisors to support compliance activities.
• Lead and participate in internal audits and assessments to ensure compliance with relevant regulations and standards and identify and address potential gaps and opportunities for improvements.
• Provide guidance and training to team members on compliance matters.
• Stay up-to-date with evolving regulations and industry trends related to medical device compliance.
• Liaise with regulatory agencies and notified bodies as necessary.

Required Skills and Experience

• 5-10+ years’ experience in medical device compliance, with expertise in software compliance.
• Bachelor's degree in a relevant field (ex. Bio-engineering, Life Sciences, Regulatory affairs or related discipline). Master’s degree preferred.
• Strong knowledge of global medical device regulations, such as FDA, EU MDR, ISO 13485, DCB and other relevant standards.
• Excellent communication, interpersonal and research skills.
• 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.
• Prior experience interacting with regulatory agencies and notified bodies.

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.