Position Overview:
The Regulatory Affairs Manager will plan, direct, and coordinate production activities of the organization to ensure compliance with regulations and standard operating procedures. The manager will also prepare submissions for therapeutic, medical, or diagnostic device licenses to various governmental regulatory agencies.
Responsibilities:
- Provide responses to regulatory agencies regarding product information or issues.
- Research FDA guidance documents for regulatory requirements.
- Direct the preparation and submission of regulatory agency applications, reports, and correspondence.
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, and compliance with regulatory standards.
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Manage activities such as audits, regulatory agency inspections, or product recalls.
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
- Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
- Develop and maintain standard operating procedures and train staff on regulatory policies/procedures.
- Contribute to the development and implementation of strategic business operating plans.
- Establish regulatory priorities and budgets, allocate resources and workloads.
Qualifications:
- Bachelor’s degree in related scientific discipline. Higher degree/PhD preferred.
- 3 – 5 years regulatory experience with medical devices and diagnostics, including managing people and projects.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society)
- Experience with compliance software such as Aris Global Register and SAP EHS Management.
- Experience interacting and negotiating with the FDA, specifically the Division of Chemistry and Toxicology Devices within OHT7 of CDRH
- Experience with filing 510(k) submissions and technical files
- Thorough understanding of FDA regulations and requirements
- Ability to manage complex projects
- Ability to independently identify compliance risks and escalate when necessary
- Strong oral and written communication and presentation skills
- Must be fluent in English and Chinese, Mandarin preferred.
About us
Wondfo Biotech Co., Ltd, located in Guangzhou China, is a world renowned rapidly growing POCT manufacturer specializing in diagnostic reagents and equipment of IVD realm.
Founded in 1992 and owning more than 22 years R&D experience, Wondfo Biotech has established one R&D center in San Diego, one branch in Chicago and nine additional global offices now. Wondfo’s products have been distributed to over 120 countries, supplying over 136,800 healthcare institutions and benefiting 2,895,780,000 people worldwide. Wondfo Biotech is devoted to making the world a better place by providing innovative POCT products.
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