R&D Document Associate (Korean/English Bilingual)
Location
Somerset, NJ | United States
Job description
Title: R&D Document Associate
Division: Research and Development
Report Line: R&D Director
Travel: Occasionally
Primary responsibility is to support the domestic and international standards from research and development through to project process and ensure compliance with all U.S. and international regulatory requirements pertaining to product approval.
Represents the Regulatory Affairs function in assigned project and completes projects and tasks to established timelines to meet corporate objectives. Negotiates the content and structure of design filings with domestic and international partners, agents for each assigned project. Develops, prepares, and maintains R&D project documentation and interacts with regulatory affairs department to achieve timely approvals.
Duties and Responsibilities - Maintains up-to-date knowledge on domestic and international regulatory requirements, and effectively communicates requirements to project team members.
- Interpret existing or new regulatory requirements as they relate to company products and procedures, clinical studies, testing, records, etc. and provide internal and external standards and guidance to ensure adherence as appropriate.
- In conjunction with project teams and international partners, evaluates possible pathways to marketing authorization and with minimal Regulatory Affairs management approval, develops, refines, and executes regulatory strategies to support business goals.
- Reviews feasibility test protocols and reports, technical documents, validation protocols and reports, risk management documents, and other documents as a key member of assigned project teams.
- Review documentation related to product transfer and release.
- Negotiates with international staff and agents on technical data and project contents.
- Develops and prepares technical documentation in the US and international areas to review for the Regulatory Affairs team and to ensure timely execution.
- Implement the Design Control projects, establish appropriate risk analysis activities which include the use of risk analysis tools such as FMEA and risk analysis testing to understand and mitigate risk.
- Updates departmental procedures which are related to the R&D department as required.
- The delivery of regulatory guidance to external partners is a key activity toward assisting the Company in achieving its business goals.
- Facilitate and prepare U.S. regulatory Submission documents (Q-sub, PMA, PEUA, EUA, and 510(k)) for Next Generation RDT assays.
- Conduct trainings and/or deliver appropriate materials, as needed, in order to enhance R&D department’s knowledge of working in a regulated environment.
- Participate in business meetings with potential or existing new external partners.
- Support project team members in the creation of IVDD and IVDR Technical Files.
- Perform regulatory assessment of new and changed products.
- Perform other duties as assigned by R&D director.
- Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
Education Minimum bachelor’s degree in a scientific discipline or equivalent.
Qualifications - Minimum of 1 or 2 years of related professional experience
- Ability to document technical processes and solutions as review the relevant documents based on knowledge of regulation, science, and experience
- Expertise in Microsoft Office applications and charting programs
- Self learner
- High energy level; positive attitude; works well under stress, Strong communicator and leader.
- Hands-on, action-oriented, and able to implement effectively through team.
- Able to work autonomously in a matrix-managed organization.
- Comfortable with ambiguity and change
- Grasp of complex technical and scientific concepts in IVD reagent chemistry, laboratory automation, and components of IVD medical devices. This involves writing and reviewing protocols, reports, and other written materials.
- Understanding of US FDA regulations for In Vitro Diagnostic (IVD) or Medical Devices.
- Proficiency in creating regulatory strategies, managing design controls, and complying with both domestic and international Quality System requirements. (Preferred)
- Familiarity with cGMP/Quality Systems and knowledge of import/export requirements. (Preferred)
Job Type: Full-time
Job tags
Salary
