Senior Regulatory Affairs Manager

Company: KARL STORZ Endoscopy - America
Location: Goleta
Posted on: May 14, 2022

Job Description:

Company: KARL STORZ Imaging, Inc. (KSI) Job Code: 12251 Pay Grade: US-D18 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. JOB SUMMARY: Brief description of what this person does, in simple direct termsAll information for a worldwide approval or registration of the assigned products and projects should be available. It will be ensured that the global approvals and conformity assessment procedures run smoothly. The safety requirements for patients, users and third parties must be state-of-the-art. Assist in support of all departments on technical standards compliance questions. ESSENTIAL FUNCTIONS : List the essential duties and responsibilities of the position, in order of importance and/or amount of time spent.Prepare products for regulatory release and bring them under regulatory hold if necessary. Identify, analyze, interpret and communicate relevant global regulations and technical standards that apply to the assigned products and projects , including compilation of information from: Published regulations and standards (eg, FDA, MDR, RoHS, ISO, EN, IEC, ASTM) Published guidance documents Draft regulations and standards Regulatory and certification agency interpretations Industry practices KARL STORZ policies and procedures Provide technical expertise to the corporation in the field of medical electrical equipment safety (IEC60601-1) and medical electrical equipment electromagnetic compatibility (IEC60601-1-2): Provide training Provide technical interpretations Participate in standards committees Ensure new products meet requirements of applicable regulations and standards. Work with product development teams from product conception to development and thru 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 Participate in the risk management process; identify hazards, assess risks, establish mitigation measures, evaluate residual risks. Perform subsequent audit of risk mitigation measures. Review test plans and 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 Design History File reviews and product release Take a leadership role in Risk Management at KSI and influence within the corporation: Ensure current and upcoming ISO14971 requirements are included in the KARL STORZ Risk Management process and procedures. Participate is all KSI product Risk Management activities Ensure consistent application severity grading and probability rating at KSI and lead process for consistent severity grading within the corporation Manage post-market failure analysis and risk review for KSI products Submit product and documentation to relevant safety and test agencies (eg, CSA, T-- --- -V, Northwest Labs): Compile documentation and samples for submittal to agencies Interface with agencies on cost estimates and timelines for product certification Point of contact with regulatory agencies to resolve issues Creation and maintenance of safety compliance portion of DHF through product life cycle 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 Ensure appropriate controls for Engineering Change process: Change control for PMA devices Safety agency review / approval for changes to safety critical components RoHS compliance of components and finished products Person responsible for regulatory compliance. Provide audit support as needed for quality systems audits (TUV, FDA, Inter-Corporate, etc.). Act as audit host for UL and CSA quarterly inspections. Participate in investigation and resolution of customer complaints and CAPAs, as needed. ADDITIONAL RESPONSIBILITES: List other important functions that are secondary duties but may be time consuming. Annual Quality MDSAP by facility within the US Participate as a member of continuous improvement teams undertaking projects and seeking ways to improve the quality of KSI's products and services . Participate in KSI internal quality system audit program, Perform other related duties as assigned by supervisor Regular attendance is an essential job function KNOWLEDGE, SKILLS, ABILITIES: What does a person in this position need to be able to do?In-depth knowledge and experience working with electro-mechanical software driven medical devices: Safety Standards, particularly; EN-60601, IEC 60601-1 and its supporting horizontal and vertical standards within U.S. and Canadian regulatory standards EU Directives, particularly; MDR, EMC, and Low Voltage Directives, RoHS, REACH ISO 9001, ISO 13485 and ISO 14971, MDSAP FDA Quality System Regulation Excellent written and oral communication skills. Training skills and public speaking experience. Proven ability with Word Processing, Excel, Visio and other Microsoft Office applications Experience with SAP preferred Knowledge of medical device quality system regulations and standards (eg, MDR Annex IX, U.S. FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001, MDSAP) EDUCATION AND EXPERIENCE: What is the usual educational background and work experience of an individual qualified to perform this job? Bachelor's degree in Engineering or related technical field with 10 plus years' experience in medical device regulatory compliance standards and quality systems or Master's degree in Engineering or related technical field with 7-11 years of experience in medical device regulatory compliance standards and quality systems. 4 years of professional experience in regulatory affairs or in quality management systems relating to medical devices. Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing. Experience serving on international technical standards committees for product safety and EMC. Experience in training groups and in public speaking. Experience with SAP preferred. Experience in training groups and in public speaking. Experience in KARL STORZ structures and business acumen. PHYSICAL & MENTAL REQUIREMENTS: What are specific physical and mental demands of this position? Ability to move around all areas of the facility Ability to work on a computer for extended periods Ability to lift 30 lbs. Ability to travel to other KS sites globally (10-20%). TRAINING REQUIREMENTS: Safety, regulatory compliance, legal & job specific Injury and Illness Prevention Program; annually - OSHA requirement Job Specific - In house requirement further see Quality Matrix SUPERVISORY RESPONSIBILITIES: List job titles supervised by this position. No direct reports. LEVEL OF SUPERVISION REQUIRED: How closely is this position supervised day to day? Minimal INTERFACE: (Internal/External Customers) List positions, work groups, departments. Close interface with the Engineering Management Team for product development projects Close Interface with global regulatory groups to identify regulations and standards and to provide technical documentation for regulatory submissions Interface with Engineers and project teams to exchange technical information Interface with Product Management teams to exchange about product, clinical and usability information Interface with Manufacturing, Materials and Distribution on product related issues Interface with Engr Document Control to ensure documented product compliance It is each employee's obligation to consistently treat visitors, external customers and all co-workers with courtesy and respect #LI-LS1Vaccine 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 on 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 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 Tuition reimbursement of up to $5,250 per year Fitness reimbursement 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 for where required by state law. Non-employees, including temporary workers and consultants, are not eligible to participate in KARL STORZ benefits program. 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 TaleoAdministrator@. 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 KARL STORZ Human Resources department will be ineligible for referral fees.

Keywords: KARL STORZ Endoscopy - America, Santa Barbara , Senior Regulatory Affairs Manager, Executive , Goleta, California