Regulatory Intelligence Manager
Company : KARL STORZ Endoscopy-America, Inc. (KSEA)
Job Code : 13465
Pay Grade : US-D18
Salary Range : $95,000 - $151,500
Description
KARL STORZ SE & Co. KG based in Tuttlingen, Germany, is a family-owned, global company committed to benefiting humanity by advancing medical technology through innovation and education.
For more than 75 years, KARL STORZ has been dedicated to earning its international reputation as a leader that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness.
KARL STORZ is currently searching for a Regulatory Intelligence Manager who will assure that all information for a worldwide approval or registration for the assigned products and projects is available.
This position will be responsible for ensuring state-of-the-art requirements, defined by regulatory bodies, are included in the new product development or product change for the assigned products;
ensuring all global approvals and conformity assessment processes meet current regulatory requirements (support enhancements / updates as required) and assist in meeting all Regulatory compliance objectives.
Responsibilities
- Prepare products for regulatory release.
- Identify, analyze, interpret, and communicate relevant global regulations and technical standards that apply to the assigned products and projects , including compilation of information from :
Global Regulatory Assessments
- Published regulations and standards (e.g., FDA, MDR, RoHS, ISO, EN, IEC, ASTM)
- Published guidance documents
- Draft regulations and standards
- Regulatory and certification agency interpretations
- KARL STORZ policies and procedures
- Ensure new products meet requirements of applicable regulations and standards (State of the Art). Work with product development teams from product conception through development and during entire product lifecycle to accomplish the following :
Identify applicable standards, including electrical safety, EMC, sterility assurance, material compatibility, software, etc.
- Ensure inclusion of specific regulatory and standard requirements in product specifications
- Analyze proposed solutions and / or required components and construction
- Collaborate with the risk management team; assess risks, review mitigation measures, evaluate residual risks.
Perform subsequent audit of risk mitigation measures.
- Review test plans and design verification / validation reports
- Ensure adherence to labeling requirements as dictated by global regulatory agencies and KARL STORZ requirements (product, Instruction manual / card, shipping box, etc.)
- Perform Phase Gate Reviews (Design History File reviews) and product release
- Coordinate document submissions to KSEA and KST Regulatory departments for :
US 510k & PMA submissions
- EU Technical File compilation and CE Marking
- Other international registrations and approvals
- Assure the assigned products meet the certifications requirements to relevant standards.
Support. Provide medical electrical equipment safety (IEC60601-1) and medical electrical equipment electromagnetic compatibility (IEC60601-1-2) when applicable
Ensure appropriate controls for Engineering Change process, including :
Change control for PMA devices and / or 510k devices
- Safety agency review / approval for changes to safety critical components
- Liaison to Regulatory Affairs Material compliance group for RoHS compliance of changes to components and finished products
- Provide audit support as needed for quality systems audits (TUV, FDA, Inter-Corporate, etc.). Support resolution of internal / external audit findings related to Regulatory Compliance.
- Participate in investigation and resolution of customer complaints and CAPAs, as needed.
- Participate as a member of continuous improvement projects / teams seeking ways to improve the quality of KSE's products and services.
- Participate and influence US National Standards Committees as requested in coordination with Corporate Regulatory Compliance.
- Perform other related duties as assigned by supervisor
- Regular attendance is an essential job function
Requirements
- Bachelor's degree in Engineering or related technical field with 7+ years' experience in medical device regulatory compliance or Master's degree in Engineering or related technical field with 5+ years of experience in medical device regulatory compliance.
- Knowledge and experience working with electro-mechanical software driven medical devices.
- Knowledge of EU Directives, particularly; MDR, Machinery Directive, EMC Directive and Low Voltage Directive.
- Familiarity with Medical Device Compliance guidance / standards - EMC ( e.g. IEC / EN 60601-1-2) and Electrical safety (e.
g. IEC / EN 60601-2-18), Software (e.g. IEC / EN 62304), Biocompatibility (e.g. EN / ISO 10993 series), Sterilization (e.
g. EN / ISO 113X), Labeling (e.g. EN / ISO 15223), etc.
- Knowledge of medical device quality system regulations and standards (e.g. EN / ISO 13485, FDA QSR, MDSAP, etc),
- Understanding the application of Risk Management principles (e.g. EN / ISO 14971)
- Excellent written and oral communication skills.
- Results oriented, and ability to manage multiple projects simultaneously
- Proven ability with Word Processing, Excel, Visio and other Microsoft Office applications
- Ability to travel to other KS sites globally (10-20%)
Preferences
- Experience with SAP preferred.
- Experience in Project Management preferred.
- Experience in KARL STORZ structures and business acumen preferred
LI-CW1
Pay Transparency
The salary 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.
Vaccine requirements at KARL STORZ due to COVID-19
KARL STORZ is committed to maintaining a safe work environment for our employees and therefore we require the COVID-19 vaccine for all of our employees unless otherwise due to an underlying medical condition or sincerely held religious beliefs.
During the interview process, we encourage you to ask how COVID-19 may impact the role you are seeking and if you require a reasonable accommodation regarding the vaccine requirement see below for the process for requesting accommodation.
Please click here to learn more about our overall response to COVID-19.
Employee Benefits Program Overview for U.S. Locations
- Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too!*
- 3 weeks vacation, 10 holidays plus paid sick time*
- Up to 8 weeks of 100% paid company parental leave
- 401K retirement savings plan providing a match of 60% of the employee's first 6% contribution
- Section 125 Flexible Spending Accounts
- Life, STD, LTD & LTC Insurance
- We prepay your tuition up to $5,200 per year! - Tuition preimbursement
- Fitness reimbursement of up to $200 annually
- Employee referral program of up to $2,000 per hire
- And much more!
- Field sales, internships, and part-time employees are not eligible except where required by state law.
Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program.
To include, maternal / paternal leave, adoption, and fostering of a child.
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.
Employee must comply will all applicable KARL STORZ policies and procedures.
Equal Employment Opportunity & Reasonable Accommodation Statement
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]
Notice to Employment Agencies
This recruitment assignment is being managed directly by KARL STORZ's Human Resources team. Human Resources will reach out to our preferred, contracted agency partners in the rare instance additional talent options are required.
Your respect for this process is appreciated. KARL STORZ does not accept unsolicited Agency resumes. Resumes received which were unsolicited by the KARL STORZ Human Resources department will be ineligible for referral fees.
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