This is a remote position.
Job Role : Japan, Korea, Brazil Medical Device Compliance and Testing Consultant III – Medical Device (United States - Remote )
Overview:
From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at and follow us on LinkedIn:
Our Fortune 500 client ha s an exciting opportunity for a Japan, Korea, Brazil Medical Device Compliance and Testing Consultant III
Job Summary:
We are seeking a highly skilled and knowledgeable Medical Device Compliance and Testing Consultant III to join our team. This role requires expertise in international electrical medical equipment (capital equipment) standards, with a focus on Japan, Korea, and Brazil. The successful candidate will play a critical role in ensuring our medical devices meet the stringent regulatory requirements of these markets.
Key Responsibilities:
International Standards Familiarity and Application:
Possess comprehensive knowledge and experience with international electrical medical equipment (capital equipment) standards, specifically for Japan, Korea, and Brazil .
Assess type testing requirements for electrical medical equipment per the standards of these regions.
Protocol Assessment and Collaboration:
Evaluate test lab protocols to ensure compliance with Japanese, Korean, and Brazilian standards.
Collaborate with test labs to update protocols as needed to meet the required standards.
Cross-Functional Coordination:
Work closely with client’s engineers in the US and Israel to determine the representative configuration of medical equipment to be tested.
Ensure that test execution is performed according to the appropriate standard protocol.
Documentation and Reporting:
Write detailed internal summary reports documenting the traceability of the test console, test results, and any interpretations made by the test lab.
Solicit and incorporate feedback from cross-functional Quality and Regulatory partners to enhance the testing and compliance process.
Qualifications:
Proven 10+ years of experience with international electrical medical equipment standards, especially those applicable in Japan, Korea, and Brazil.
Ability to assess and ensure compliance of test lab protocols with international standards.
Strong collaboration skills to work effectively with engineers and test labs across different locations .
Excellent documentation and reporting skills to provide clear and detailed internal reports.
Familiarity with cross-functional Quality and Regulatory processes within a medical device company.
Strong problem-solving skills and attention to detail.
Must have strong knowledge and experience in compliance protocols of Pharmaceuticals and Medical Devices Agency (PMDA), Ministry of Food and Drug Safety (MFDS) and Agência Nacional de Vigilância Sanitária (ANVISA).
Preferred Qualifications:
Candidat e has a medical laser experience
Other Details:
Work Set Up: Remote
Contract Length: 3-6 months
Travel: 10% possibility - in MA, MN, or Ireland for training
EEO Employer:
Pharmavise Consulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Pharmavise Consulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please contact info@pharmavise.com .
Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you join Pharmavise, you become part of a team that values Excellence Through Quality.
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