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Regulatory Engineer
4 months ago
Eastridge Workforce Solutions is a leading provider of workforce management solutions, committed to connecting skilled professionals with meaningful career opportunities. Join a leading global medical device company committed to innovation and excellence in the healthcare sector. Our client designs and develops cutting-edge medical technology that improves patient outcomes and enhances the quality of life. We are looking for a dedicated and skilled Regulatory Engineer to enhance their regulatory affairs team.
Job Description:
As a Regulatory Engineer, you will be instrumental in ensuring our medical devices, both implantable and non-implantable, meet the regulatory standards of PMDA and China FDA. This role involves a blend of quality control, research & development, and manufacturing oversight to support our products' compliance across international markets.
Key Responsibilities:
- Lead the preparation and submission of regulatory documents to PMDA and China FDA.
- Collaborate with cross-functional teams, including R&D and Manufacturing, to ensure regulatory requirements are integrated throughout the product development process.
- Monitor regulatory developments within the medical device sector in China and internationally.
- Assist in the development and updating of internal regulatory strategies and policies.
- Ensure that our products continuously meet the standards required by regulatory bodies.
Requirements:
- Bilingual proficiency in Chinese and English.
- At least 2 years of professional experience in regulatory affairs specifically dealing with PMDA and China FDA for implantable or non-implantable medical devices.
- Previous work experience in the United States or China, with a background in Quality, R&D, or Manufacturing within the medical device field.
- Experience in the pharmaceutical or biomedical sectors is preferred.
- Bachelor’s degree in Engineering, Regulatory Affairs, or a related field.
- Strong understanding of regulatory requirements and procedures for medical devices.
- Excellent organizational, communication, and leadership skills.
Benefits: Use this link bit.ly/2023-Benefits to learn more about benefits available to Eastridge’s temporary employees.From time to time Eastridge’s clients may offer additional benefits to Eastridge employees while on assignment.Information about those benefits will be communicated when applicable.
Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.
Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
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