Senior Manager, Medical Device Regulatory Affairs

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.

Senior Manager, Medical Device Regulatory Affairs

We are seeking a highly skilled and experienced Senior Manager in Medical Device Regulatory Affairs to lead and drive the development of regulatory strategies and compliance for our innovative medical devices. The successful candidate will play a pivotal role in guiding cross-functional teams to establish and maintain regulatory processes, ensuring that our products meet global standards.

Key Responsibilities:

• Transformational Leadership: Provide visionary leadership to all departments and functions involved in building and enhancing the medical device infrastructure and capabilities.
• Regulatory Strategy: Develop and implement comprehensive regulatory strategies/roadmap to ensure product compliance with US FDA CFR, EU Medical Device Regulation, and global Medical Device Regulations.
• Global Regulatory Affairs: Lead efforts in global regulatory affairs, managing submissions, communications, and interactions with regulatory agencies worldwide.
• Quality Assurance: Partner with Enterprise QA & Operations Quality teams to ensure adherence to applicable ISO standards, such as ISO 13485 and ISO 14971 Risk Management for Medical Devices.
• Cross-functional Collaboration: Collaborate with Product Management, R&D, Quality Assurance, Operations and Regional teams to ensure the seamless integration of regulatory requirements into product development all the way through production realization at the Customer.
• Compliance and Audits: Ensure that the organization is fully compliant with all relevant regulatory requirements and standards. Partner with Enterprise QA to prepare for and manage regulatory audits as required.
• Establish stakeholders and communication plan for BU and the rest of the organization on regulatory requirements on existing and newly issued regulations/professional standards.
• Train and coach applicable employees in Stratasys policies, procedures, processes, and practices
• Lead and participate in the development and/or review of training, presentations, and other learning materials.
• Manage multiple projects of varying complexity and other actions to help the BU with successful implementation as agreed on with affected stakeholders.
• Manage small team to execute BU regulatory roadmap projects.

Qualifications (minimum):

• Bachelor’s degree in a scientific discipline is required.
• Minimum of 10 years of industry experience within a medical device manufacturing environment.
• 8+ years of hands-on experience in Global Regulatory Affairs, including regulatory submissions and interactions.
• 6+ years of Quality Engineering and/or Quality Systems experience in the medical device industry.
• 5+ years experience in managing teams
• Proficiency in medical device design control processes.
• Strong knowledge of US FDA CFR, EU Medical Device Regulation, and global Medical Device Regulations.
• Experience working with ISO 13485 and ISO 14971 Risk Management for Medical Devices.

Skills and Competencies:

• Excellent leadership and management skills.
• Exceptional problem-solving and decision-making abilities.
• Strong communication and interpersonal skills to effectively interact with regulatory agencies and internal teams.
• Attention to detail and a commitment to maintaining high-quality standards with ability to guide cross-functional teams through risk management processes.
• Ability to adapt to evolving regulations and industry standards and guide the business via a robust change management approach.
• Able to work with a diverse group of individuals and styles, internally (employees, senior leadership) and externally (consultants, Regulators)

Qualifications (preferred):

• Additive manufacturing experience
• Experience in standing up company medical device infrastructure.

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