Medical device projects manager

We at Stratasys are passionate believers in the value and power of 3D printing, and in the change it can bring to design, innovation and manufacturing.

The solutions we create are used by over 20,000 enterprises worldwide, and are rapidly changing the way products are imagined, designed, marketed, produced, supplied and sold. We are literally shaping the world that surrounds us – from the products and services in our lives and homes, to our health and quality of life, our transport, security and economies, to how we teach, research and even learn.

Stratasys is the largest 3D printing solutions’ company in the world – a company at the forefront of 3D printing innovation for more than 25 years

We are seeking an experienced and dynamic Medical Device/Regulatory Affairs Projects Manager to join our RA team. The ideal candidate will possess a strong background in project management, regulatory affairs, and a deep understanding of medical device design and development processes. This role requires excellent communication, planning, and execution skills to ensure the successful execution of projects in compliance with regulatory standards, including but not limited to ISO13485, 21CFR820, MDR, MDSAP.

Responsibilities

• Project management:
• Lead and manage cross-functional teams to ensure the successful planning, execution, and completion of medical device projects.
• Develop and maintain comprehensive project plans, including timelines, milestones, and deliverables.
• Monitor project progress, identify potential risks, and implement effective mitigation strategies.
• Facilitate collaboration between regulatory, quality, and engineering teams to achieve project objectives.
• Work closely with product development teams to understand the intricacies of the design and development process for medical devices.
• Regulatory Affairs:
• Stay abreast of both internal and external QMS and regulatory requirements, including ISO13485, 21CFR820, MDR, MDSAP, and ensure compliance throughout the project lifecycle.
• Ensure that design controls are implemented and maintained in accordance with regulatory requirements.
• Prepare and submit regulatory documentation, including regulatory submissions and compliance reports.
• Collaborate with regulatory authorities to address inquiries and facilitate approvals.
• Communication:
• Foster clear and open communication within the project team and with key stakeholders.
• Provide regular updates on project status, milestones, and regulatory compliance to management and relevant departments.
• Serve as a point of contact for regulatory agencies, ensuring effective communication and collaboration.
  
  

• Bachelor’s degree in a scientific discipline (e.g., Biology, Biomedical Engineering)
• 3+ years industry experience with a medical device company.
• Broad understanding of key elements of Quality Systems.
• Strong understanding of the medical device design and development process.
• Proven experience in project management within the medical device industry.
• Strong knowledge of FDA\EU regulations, ISO13485, ISO 14971.
  
  

• Strong organizational and communication skills, both written and presentation.
• Able to work with a diverse group of individuals and styles, internally (employees) and externally. (consultants)
• Excellent communication and interpersonal skills.
• Ability to lead cross-functional teams and drive project success.
• Detail-oriented with a focus on quality and compliance.
• Respect and adherence to timelines
• Excited for start-up culture: adaptability, occasional ambiguity, limited resources, willingness to do what is necessary to get the job done.
• Self-motivated, willing to learn.