TÜV SÜD America Inc., a global leader in product safety and EMC testing, regulatory affairs and certification, has an immediate opening at our offices in the USA for a
Cardiac Implant Expert
At TÜV SÜD America, we are passionate about technology, people and the environment. For almost 150 years, our employee’s contributions and enthusiasm have been essential to the success of our business. Our commitment is to invest in our employees as well as to hire, develop, and engage the best talent to help us continue to build our team. We are dedicated to creating a work environment where all levels of employees are inspired to learn, grow, and be empowered to achieve both their professional as well as personal goals.
We are looking for personable and outgoing individual who will work closely with our medical device customers. This position will be the key contact to proactively provide superior customer service to customers. Your role and responsibilities include assessment of non-active medical devices – with special focus on cardiac implants - and their manufacturers per the European Medical Devices Directives, other applicable Regulatory Systems and International standards, including related client and project management. We are looking for a detail oriented individual with conformity testing experience, ideally within the medical / regulatory field and who wants to add value to our organization.
Roles & Responsibilities
Perform regulatory audits of clients per European Medical Device Directives (AIMD, MDD, IVDD), Canadian Medical Device Regulations (CMDR), Japanese Pharmaceutical Affairs Law (JPAL) and International quality system standards (e.g. ISO 13485) as well as internal Notified Body and TÜV SÜD America criteria including all related tasks, such as scheduling, planning, reviewing corrective actions, preparing reports and audit documentation for submission to the certification committee of the Notified Body.
Provide project management for NAFTA-based customers. Project management potentially consists of issuing quotes, coordinating multiple projects, coordinating audit team, and answering client questions.
Communication / Customer Service:
Communicate in a courteous and effective manner with internal and external customers in all circumstances including answering questions, relaying messages, and providing information with regard to standards, regulatory and technical requirements for compliance with standards and the respective regulatory system.
Keep abreast of present and pending regulatory requirements, standards and TÜV SÜD America service capabilities through internal training sessions, external seminars, and reading of scientific articles.
The ideal candidate will have a MS or PhD Degree in a science related field (biotechnology, biology, chemistry, mechanical engineering, etc.)
Minimum of 5 years experience in an industrial medical device environment on the area of Product Designer / Product Development Scientist of cardiac implant;
Spanish language a plus.
Regular domestic travel and international travel is required.
Why should you join TÜV SÜD America?
Competitive compensation package that includes health & dental insurance
401(k) retirement savings plan with matching contributions
Paid Time off for volunteering in the community
Fitness and Weight Loss Reimbursement through our Health Plan
Additional rewards for leading a healthy lifestyle
Health & Wellness Education
Employee Assistance Program - a program of services that provides assistance to employees and families with balancing the demands of work and home.
Corporate sponsored running and walking events
Company sponsored outings and holiday events
Softball and Bocce Tournaments
Opportunities to expand your career internationally and work alongside people from diverse cultures and backgrounds
Develop and grow in a performance-based environment that recognizes and rewards top performers
Continuous training and learning opportunities to support the professional and personal development of our employees
Work alongside experts and market leaders in a company with a strong recognizable brand worldwide
Make a positive contribution to change and progress; doing your part to ensure safety, quality and environmental sustainability
We look forward to hearing from you! Click on Apply Now button for quick and easy aplication process guidelines.
Or, if you prefer, please email your resume and cover letter, clearly stating the position you are applying for, to:
TÜV SÜD America, Inc. is an equal opportunity, affirmative action employer and considers qualified applicants for employment without regard to race, color, creed, religion,ancestry, marital status, genetics, national origin, sex, sexual orientation, gender identity and expression, age, physical or mental disability, veteranstatus and those laws, directives, and regulations of Federal, State, and Local governing bodies or agencies.