Technical Reviewer - Medical and Health Services
Company: TUV SUD America
Posted on: January 5, 2020
Technical Reviewer - Medical and Health Services 125999 Full time
regular Professionals 3 - 5 years of experience Medical Devices &
Healthcare Your responsibilities will include, but are not limited
- Perform technical assessments of audit and project files with
certification decision based on requirements from ISO 13485, ISO
9001, MDSAP, AIMDD/MDD/IVDD.
- Answer internal and external requests regarding regulatory
- Perform evaluations of regulatory submissions including: Design
Dossier (EU Directives), Technical File Review (EU Directives).
- Continuously look for improvement in business processes and
software solutions identify, champion, and maintain said
- Keep abreast of present and pending regulatory requirements,
standards and T V S D America service capabilities through internal
training sessions, external seminars, and reading of scientific
- Optional and as needed, perform regulatory audits of clients per
European Medical Device Directives (MDD/AIMDD/ IVDD), Medical
Device Single Audit Program (MDSAP), 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
planning, reviewing corrective actions, preparing reports and audit
documentation for submission to the certification committee of the
- Generate metrics as required.
- Handle contract review and audit registration, as required.
- Communicate in a prompt, courteous and effective manner with
internal and external customers in all circumstances including
providing information, answering questions, and relaying
- Other tasks as needed
Immediate opening for a Technical Reviewer based in Peabody, MA,
New Brighton, MN, San Diego, CA or a Home Office.
The Technical Reviewer performs final review and release of
technical audit reports for TUV SUD America audits. The opportunity
includes interfacing responsibilities with external and internal
customers including auditing bodies, business and service units,
and other department members. Continuous improvement thinking is
encouraged. The successful candidate is detail-oriented,
enthusiastic, able to work with minimal supervision, and enjoys
coming up with creative solutions to ever more creative
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
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 links below:
EEO is the Law Poster:
EEO is the Law Poster Supplement:
Pay Transparence Policy Statement:
This job may be for you if:
- BS or MS Degree in a science related field (biotechnology,
biology, chemistry, microbiology, electrical engineering,
mechanical engineering, etc.)
- Formal training in Corrective and Preventive Actions, and Root
- 5+ years industrial medical device experience, at least 3 of them
as Quality Manager / Project Manager / Engineer / Regulatory
Affairs / Quality Assurance or related.
- 2+ years auditing experience to all or some of ISO 13485,
MDD/IVDD/AIMDD, CMDCAS, MDSAP.
- Lead Auditor Certification (including surveillance and
(re)certification audits performed).
- Experience working in an accredited Certification Body is
- Demonstrated ability to work independently and in a collaborative
- Passion for working in the medical device industry;
- Demonstrated, excellent oral and written communication
- Self-starter with a positive outlook and motivated attitude; a
commitment to self-improvement;
- Ability to successfully keep track of several projects at one
time, adhere to tight deadlines and maintain a positive, helpful
- Represent T V S D products and services in a professional
- Accurate, clear, and timely communicate of information, upward
and lateral, including verbal, written and listening skills;
- Reliable judgment that is consistent, adaptable to unusual
situations, realistic, common sense approach to job and
- Willingness to consider other s ideas and to work with others as
part of a team;
- Adaptable and willing to shift to other duties to meet changing
US-CRT-MA Boston / Peabody Massachusetts United States Home Office
Massachusetts United States
Keywords: TUV SUD America, Peabody , Technical Reviewer - Medical and Health Services, IT / Software / Systems , Peabody, Massachusetts
Didn't find what you're looking for? Search again!