Medical Device Regulatory Affairs -Projects Manager

Stratasys is a world leader in 3D printing!

Stratasys is leading the global shift to additive manufacturing with innovative 3D printing solutions for industries such as aerospace, automotive, consumer products and healthcare. Through smart and connected 3D printers, polymer materials, a software ecosystem, and parts on demand, Stratasys solutions deliver competitive advantages at every stage in the product value chain. The world’s leading organizations turn to Stratasys to transform product design, bring agility to manufacturing and supply chains, and improve patient care.

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.

Background:

• 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.

Skills:

• 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)
• 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.

What​ ​you​ ​will​ ​be​ ​part​ ​of:

• Company Overview - https://www.stratasys.com/en/about-us/history/
• Our Culture and Values - https://www.stratasys.com/en/about-us/culture/
• Our Sustainability “3D Printing a Better Tomorrow” - https://www.stratasys.com/en/about-us/sustainability/
• Our Locations - https://www.stratasys.com/en/contact-us/office-locations/
• Check out our Video - https://www.youtube.com/watch?v=6wmDfmt2bNI