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Project Manager

2 months ago

Bury St Edmunds, United Kingdom Six Ventures Ltd Full time

Exciting Opportunity: Project Manager – Medical Devices


We are excited to be working with an inspiring and fast-growing company in the Medical Device industry, dedicated to developing and manufacturing life-enhancing devices that improve patient care and transform medical treatment. With a commitment to innovation and quality, they are looking to expand their talented team and are seeking an enthusiastic Project Manager to join their dynamic environment.


Why Join?

This role offers a unique opportunity to work with cutting-edge medical technology, collaborating with a team of experts to bring transformative devices to market. As part of a company that values professional growth and teamwork, you’ll be empowered to make a meaningful impact in the healthcare field while advancing your own career.


Role Overview


The Project Manager will be instrumental in steering project teams and ensuring the development of essential technical documentation, moving innovative medical devices from initial concept through regulatory approval, and ultimately to commercial production. This role is ideal for a proactive leader who thrives in a collaborative and regulated environment.


Key Responsibilities

Your responsibilities as a Project Manager will include:

  • Documentation Support: Assist in creating detailed documentation for the regulatory submission process, ensuring compliance with all medical device standards and regulations.
  • Project Management: Oversee project timelines, allocate resources effectively, and coordinate team workloads to meet project milestones.
  • Regulatory Compliance: Maintain and generate project documentation in alignment with ISO 13485 and other relevant regulatory standards.
  • Client Collaboration: Engage directly with customers to capture essential product information, understand their needs, and translate them into actionable project goals.
  • Product Development Partnership: Work alongside the design team to craft devices tailored to meet customer specifications and high standards of quality.
  • Meeting Coordination: Lead regular internal team meetings and customer update sessions, ensuring clear communication and progress tracking.
  • Vendor and Subcontractor Liaison: Manage relationships with external partners to support various project requirements.
  • Risk Management: Conduct thorough risk assessments and hazard analyses, identifying potential issues early to mitigate risk.
  • Testing and Data Analysis: Develop product test methods, perform basic data analysis, and evaluate results to ensure product quality and safety.
  • Regulatory Adherence: Operate within all applicable quality systems, with a focus on medical device compliance and regulatory standards.
  • UK Travel: Some travel within the UK may be required to fulfill project needs and support client relationships.


Qualifications & Skills

To be successful in this role, you should have:

  • Experience: A minimum of 2 years of practical experience within medical device development, with a track record of successfully managing projects.
  • Educational Background: A degree in Bioengineering, Medical Engineering, or a related field (or equivalent experience).
  • Project Management Expertise: Previous experience managing medical device projects is ideal.
  • Regulatory Knowledge: Familiarity with medical device regulations, such as UKCA, MDR, FDA, and other relevant standards.
  • Risk Management: Proficiency in risk management and design control processes in medical device development.
  • Documentation Skills: Strong written communication and documentation skills, with proficiency in MS Office applications.
  • Organizational & Communication Skills: Excellent organizational abilities, with strong verbal and written communication skills and the ability to work cross-functionally.
  • Teamwork and Independence: Ability to work both independently and collaboratively within a diverse team environment.


What We Offer

This position provides an opportunity to join a forward-thinking company that fosters a culture of innovation, support, and continuous learning. You’ll benefit from working in a stimulating environment that values creativity, quality, and commitment to improving patient outcomes.

If you're a motivated project manager with a passion for medical technology, regulatory compliance, and project leadership, we would love to hear from you