Full-Time
Medical Device Compliance Manager
Posted on 4/7/2024
Data management and healthcare information systems
Mid, Senior
Slough, UK
- 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.
- 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.
InterSystems provides robust data management and healthcare information systems, incorporating advanced technologies like machine learning and analytics. This company is a global leader in handling extensive health records and improving significant sectors like shipping and finance through data interoperability and management. Working here means contributing to transformative projects that modernize essential industries while operating within a culture that values technological advancement and global impact.
Company Stage
N/A
Total Funding
N/A
Headquarters
Cambridge, Massachusetts
Founded
1978
6 month growth
↑ 3%1 year growth
↑ 10%2 year growth
↑ 11%Benefits
Generous parental leave
Flexible work schedule
Family medical leave
Health insurance benefits
Wellness programs
Professional development
401k
Generous PTO