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.

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.

Credentialing requirements at KARL STORZ

KARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.

Pay Transparency

The pay range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future. When determining a specific team member's base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.

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