Job Function: Patient Health & Regulatory Affairs
Location:
Charlton, MA, US, 01507
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Work Location (for field-based positions):
Work Flexibility: Hybrid
Pay Range: $113,900 - $148,100
Job ID: 5605
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.
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.
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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MA Applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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Eligible Employee Benefits
Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too!
3 weeks vacation, 11 holidays plus paid sick time
Up to 8 weeks of 100% paid company parental leave; includes maternal/ paternal leave, adoption, and fostering of a child.
401(k) retirement savings plan providing a match of 60% of the employee’s first 6% contribution (up to IRS limits)
Section 125 Flexible Spending Accounts
Life, STD, LTD & LTC Insurance
We prepay your tuition up to $5,250 per year! - Tuition pre-imbursement
Fitness reimbursement of up to $200 annually
And much more!
KARL STORZ reserves the right to change or modify the employee’s job description whether orally or in writing, at any time during the employment relationship. Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor. Employees must comply will all applicable KARL STORZ policies and procedures.
KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences. To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status, or any other protected characteristic. KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at
[email protected].
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Get in Contact
5605
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Nearest Major Market: Worcester
