As a Medical Device Compliance Manager, you will play a critical role in maintaining and enhancing the compliance standards for our medical devices, with a particular focus on software, in accordance with MDR, FDA, and DCB 0129 requirements. You will be responsible for reviewing, assessing, and resolving (issues relate to) our device manufacture and implementation strategies. The oversight of the compliance aspects of product development, regulatory submissions, and quality management systems are managed by a central compliance program, and this role is a key stakeholder for that central program.

This role will be office based in Windsor 5 days per week for the first 3 months and then revert to a hybrid model of 3 days office based in Windsor per week.

Role Responsibilities

Develop and implement compliance strategies and policies related to medical devices, with a strong focus classification and risk diligence (ISO 14971 and DCB 0129). Ensure that all medical devices (including products that can be marketed as medical device) are assessed for relevant regulatory compliance. Collaborate with cross-functional teams to integrate compliance considerations into product design and development processes. Manage and coordinate regulatory submissions and approvals for medical devices. Lead and participate in internal audits and assessments to ensure compliance with relevant regulations and standards. 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

Bachelor's degree in a relevant field (e.g., Bio-engineering, Life Sciences, Regulation). Masters, preferred. Minimum of 5 years of experience in medical device compliance, with expertise in software compliance. Strong knowledge of relevant regulations, standards, and guidelines. Excellent communication and research skills. Ability to work independently and collaboratively in a fast-paced environment. Detail-oriented with a strong commitment to quality and compliance. Prior experience interacting with regulatory agencies and notified bodies.

As an equal opportunities employer, InterSystems does not condone discrimination on the basis of age, disability, sex, sexual orientation, pregnancy and maternity, race or ethnicity, religion or belief, gender identity, or marriage and civil partnership.

We aspire to have a diverse and inclusive workplace and strongly encourage suitably qualified applicants from a wide range of backgrounds to apply and join our organisation.

About InterSystems

Established 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, 24×7 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.