Cardiovascular Product Expert
Company: TUV SUD America
Posted on: November 4, 2019
Cardiovascular Product Expert 126332 Full time regular
Professionals 3 - 5 years of experience Medical Devices &
Healthcare T V S D America Inc., a global leader in testing,
inspection and certification, has an immediate opening for a
Cardiovascular Product Expert based in a home office.
Your responsibilities will include, but are not limited to:
- Assessment of Technical Documentation: Perform conformity
assessments of regulatory submissions such as Design Dossiers and
Technical Documentations to relevant safety principles and standard
- Auditing (to limited extent): Perform regulatory audits of
clients per European Medical Device Directives (AIMD, MDD, IVDD),
Medical Device Single Audit Program (US, Canada, Brazil, Japan,
Australia) and International quality system standards (e.g. ISO
13485) as well as internal Notified Body and T V S D 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
- Project Management: 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.
- Expertise: Keep abreast of present and evolving regulatory
requirements, standards and T V S D America service capabilities
through internal training sessions, external seminars, and reading
of scientific articles.
At T V S D America, we are passionate about technology, people and
the environment. 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.
For over 30 years, T V S D has provided market access solutions and
expert partnership for medical device manufacturers and suppliers.
Our dedicated team of over 500 medical experts, engineers, and
doctors, positioned all over the globe, provide assessments that
cover the full life cycle of your medical device - including
initial product designs, risk management, clinical and
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
active medical implants per the European Active Implantable Medical
Device Directive, Essential Requirements 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.
It is T V S D s priority to stay true to our founding principle by
creating a safer and more sustainable future. To protect people,
property and the environment from technology-related risks now and
in the future, our experts are driving the development of four
strategic themes: consumer protection, digital transformation,
sustainable development and urbanization. To learn more about T V S
D, visit T V S D America today!
We offer a competitive compensation package that includes health
insurance and participation in the company 401(k) retirement
T V S D 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, veteran status
and those laws, directives, and regulations of Federal, State, and
Local governing bodies or agencies. We participate in the E-Verify
Employment Verification Program.
For more information on applicable equal employment regulations,
please refer to the following:
EEO is the Law Poster:
EEO is the Law Poster Supplement:
This job may be for you if have:
- Minimum BSc degree in biomedical, electrical, or mechanical
engineering or equivalent
- Four years work experience in Candidates with experience in
Design Assurance, combination of Regulatory Affairs with R&D,
Quality are preferred.
- Experience with Functional area of Electrophysiology catheters
such as Ablation catheters, structural heart including heart
valves, transcatheter heart valves etc.
- A relevant master s degree substitutes one-year work experience,
and a relevant PhD degree substitutes up to three years of four
years of work experience
- Sound knowledge in regulatory requirements, e. g. MDD (93/42/EEC)
and other related requirements
- Sound knowledge in product, technology quality, or other related
- Orientation towards the safety and performance of medical
- Precision and accuracy
- Ability to work in an intercultural environment
- Demonstrated experience in Project Management preferred.
- Proficiency in MS Office
- Common sense and pragmatism
- Auditor according to ISO 13485 and MDD / AIMDD and CMDCAS and
JGMP (a plus)
Willingness to travel (domestic and international)
US-MHS-PA-APP Home Office United States
Keywords: TUV SUD America, Peabody , Cardiovascular Product Expert, Other , Peabody, Massachusetts
Didn't find what you're looking for? Search again!