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Date Posted:06/Dec/17Requisition:2073697Job Title:Medical Device Compliance Engineer (m/f)Description:Agilent Technologies – we stand for high-tech and laboratory expertise around the world. As a worldwide company based in Santa Clara (California/USA), in the heart of Silicon Valley, we offer instruments, software, services and supplies for the entire workflow in the analytical laboratory. Our solutions and products are used among other things for the development of new drugs, for food testing, in cancer research and in doping control. We inspire discoveries that advance the quality of life. At our German headquarters in Waldbronn we develop, produce and market leading comprehensive analytic solutions. Along with our sales offices in Munich, Frankfurt, Hamburg and Ratingen, there is a staff of about 1,000 in Germany.
The LSAG Medical Device Regulatory Team is seeking a Medical Device Compliance Engineer (m/f) to support all regulatory aspects of medical device products in LSAG. The person will work closely with the enterprise QA/RA function as well as division quality and other business functions to manage day-to-day regulatory compliance processes such as complaint handling, design control (risk mgmt, design review, PLC consultancy), change management of released products (DHF mgmt, RA review for ECO/ECR).
• Provide regulatory support and to assure compliance for current products and processes
• Assist with FDA facility inspections and notified body audits
• Interact closely with enterprise QA/RA to identify relevant standards and guidance documents that affect LSAG’s business and products
• Assist in the assessment and identification of regulatory strategies for LSAG products/projects
• Participate on project teams to define regulatory requirements of U.S. and international markets
• Bachelors, Masters or University Degree or equivalent in Engineering or Scientific/Technical discipline preferred; may consider other education and/ or combination of education and experience.
• 3+ years relevant industry experience.
• Familiarity or expose to handling FDA complaints, product labeling and associated regulatory activities is required.
• Knowledge of medical device / IVD regulations such as FDA, EU, … and related ISO standards such as ISO 13485, ISO 14969, ISO 14971
• Knowledge and practical experience in statistics
• Experience and/or knowledge of other QMS standards (e.g. auditor qualification) and ability to compare and contrast QMS standards (e.g. ISO 13485 vs ISO 9001)
• Effectively interacts and understands the different levels of an organization
• Demonstrates strong teamwork skills and is able to lead, collaborate and work effectively in teams across different businesses, functions and geographies
• Has a sensitivity for working with other cultures
• Good communication skills (oral, written and presentation)
• Willingness to work globally within different time zones
• Company pension scheme
• Work-Life-Balance programs
• Career development opportunities
Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster available here:
Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please contact +1-262-754-5030 (US and Canada only) or email firstname.lastname@example.org. EOE AA M/F/Vet/DisabilityCompany:Business:Life Sciences and Applied Markets Group
Country or Area:State/Province:Town/City:Shift:Day Job
(Temp Positions Only):Not applicable
HR Country Location:Germany
HR Town/City Location :Waldbronn