カールストルツ・エンドスコピー・ジャパン（株）
Regulatory Intelligence Manager
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About KARL STORZ
From the operating room to surgery centers—and everywhere in between—KARL STORZ North America is a global leader in medical technology and advanced visualization solutions. We design specialty innovations, smart instruments and devices, integrated ecosystems, and intelligent imaging—to build a more connected, software-enabled operating room.
As an independent, family-owned MedTech company, we ambitiously think in generations instead of quarters to improve patients' lives around the world.
About The Role
As a Regulatory Intelligence Manager, you'll play a key role in ensuring our innovative medical technologies meet global regulatory, safety, and compliance requirements throughout the product lifecycle. Working closely with Engineering, Quality, Product Management, and Global Regulatory Affairs, you'll provide technical expertise that supports new product development, engineering changes, worldwide regulatory submissions, and global market access.
This is an exciting opportunity for an experienced regulatory professional to influence product development from concept through commercialization while helping bring safe, compliant medical devices to healthcare providers around the world.
This role has a hybrid work schedule – 2 days from home and 3 days in our Charlton, MA office.
What You'll Do
- Serve as the regulatory compliance lead for assigned medical device products throughout the product development lifecycle.
- Interpret and apply global regulations, standards, and guidance, including FDA, EU MDR, ISO, IEC, EN, ASTM, RoHS, and other international requirements.
- Partner with Engineering and cross-functional teams to ensure regulatory requirements are incorporated into product design, verification, validation, and product release activities.
- Review engineering documentation, Design History Files (DHF), risk management documentation, labeling, and technical reports to ensure regulatory compliance.
- Support global regulatory submissions, including FDA 510(k), PMA, CE Marking, EU Technical Documentation, and international product registrations.
- Collaborate with Regulatory Affairs, Quality, Manufacturing, and Product Management to support engineering changes, compliance initiatives, and product lifecycle management.
- Participate in quality system audits, CAPA investigations, customer complaint reviews, and continuous improvement initiatives.
- Monitor changes in global regulations and industry standards to assess business impact and maintain ongoing product compliance.
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What You Bring
- Bachelor's degree in Engineering or a related technical discipline.
- Minimum of 7 years of experience in medical device regulatory compliance.
- Strong knowledge of FDA regulations, EU MDR, ISO 13485, MDSAP, and other global medical device regulatory requirements.
- Experience interpreting and applying medical device standards related to electrical safety, EMC, software, biocompatibility, sterilization, labeling, and risk management.
- Experience supporting global regulatory submissions, including FDA 510(k), PMA, CE Marking, and international market registrations.
- Proficiency with Microsoft Office applications, including Word, Excel, and Visio.
- Excellent written, verbal, and interpersonal communication skills with the ability to collaborate across cross-functional teams.
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What Will Make You Successful
- Strong understanding of medical device product development and regulatory compliance throughout the product lifecycle.
- Ability to interpret evolving regulations and translate requirements into practical engineering and compliance solutions.
- Strong analytical, problem-solving, and organizational skills with exceptional attention to detail.
- Ability to manage multiple priorities while working effectively in a collaborative, fast-paced environment.
- Experience partnering with Engineering, Quality, Manufacturing, Product Management, and Regulatory Affairs teams.
- Experience supporting quality system audits, CAPA activities, and continuous improvement initiatives.
- Master's degree in Engineering, experience with SAP or project management tools, and familiarity with medical device quality systems are preferred.
Why KARL STORZ?
Join KARL STORZ and be part of a team creating medical innovations that truly make a difference. Beyond technology, you'll be part of a culture that values talent as its greatest asset, empowering you to contribute to a mission that improves patient care worldwide. As a global MedTech leader, we invest in our people, foster innovation, and provide opportunities to grow your career while helping shape the future of healthcare.
Ready to make an impact? Apply to be our next Regulatory Intelligence Manager and help us build the future of MedTech together.
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