Compliance Specialist

4 weeks ago

Windsor, Windsor and Maidenhead, United Kingdom InterSystems Full time
Job Title: Compliance Specialist

As a key member of the Risk & Compliance team at InterSystems, you will play a critical role in ensuring the company's software solutions comply with regulatory requirements, standards, and guidelines related to medical device software. 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 the Software Development Lifecycle.

Key Responsibilities:
  • Consult with departments to educate and support them in meeting their compliance goals.
  • Maintain current knowledge on relevant certifications (ISO / 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.
  • Manage relationships with external consultants and advisors, as well as internal stakeholders, to support compliance activities.
  • Lead and participate in internal audits and assessments to ensure compliance with relevant regulations and standards.
Requirements:
  • 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, ISO, IEC, 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 into understandable guidance for teams and services.
  • 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.

InterSystems is an equal opportunities employer and 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.

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