メディカル・バイオ - 薬事申請
Principal Duties and Responsibilities
■General Duties and Responsibilities
・Develop positive relationships with clients, as well as with NAMSA colleagues.
・Ensure that products and deliverables are of high quality given time and budget constraints.
・Function at a level that affords respect by internal NAMSA Associates/team members.
・Communicate project/team issues to Regulatory Specialist and/or Manager.
・Function as a productive project team member.
・Assist in presentations, including preparation of slides, and speaking.
・Perform project in compliance with regulations and NAMSA policies and procedures.
・Establish and ensure schedule, budget and quality commitments are met for the client.
・Manage (motivate, communicate) internal team members.
・Understand investigational product(s) and high level understanding of the Medical Device Development Process.
・Handle challenging and/or novel situations. Uses judgment to determine when issues should be escalated.
・Interact as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
・Perform project in compliance with regulations.
・Effectively manage multiple projects and perform with accuracy and a high attention to detail
・Deliver presentations, including preparation of slides, and speaking.
・Propose and implement systems to support internal improvement and NAMSA’s long-term growth.
■Marketing Duties and Responsibilities
・Participate in meetings with prospective clients.
・Assist in obtaining and providing scope of project and relevant information to support the creation of proposals.
・Identify opportunities to bring in new projects/clients.
・Offer opportunities to clients for expansion of MRO services to be provided by NAMSA.
・Actively participate and lead meetings with prospective clients.
・Obtain required scope of work to support creation of proposals.
・Speak at conferences, webinars, or other marketing venues.
・Conduct training and/or seminars for clients on current and forthcoming regulatory topics.
■Role-Specific Duties and Responsibilities
・Assist/conduct research on regulatory or scientific issues as required.
・Assist with literature search and summary related to product type and submissions.
・Identify product Class and assist in developing regulatory assessments and strategy, SOPs and WIs, registration and listings under direction of Regulatory Specialist or Manager.
・Compile, write and/or submit regulatory submissions under direction of Regulatory Specialist or Manager.
・Assist in developing Pre-Submission/IDE packets for meetings with PMDA and / or CE, FDA, NMPA.
・Participate in calls to PMDA and / or CE, FDA, NMPA for client.
・Coordinate, write, review and/or submit regulatory submissions (including but not limited to pre-submission meetings, IDEs, 510(k), and Design Dossiers).
・Write, review, and assess test protocols and reports.
・Coordinate, write and review regulatory assessments.
・Assist clients in identifying required pre-clinical testing.
・Perform literature reviews.
・Develop regulatory strategies and participate in regulatory agency meetings with clients.
・Identify and interpret Standards and Guidance Documents applicable to medical devices.
・Able to professionally interact directly with government entities (e.g. PMDA and /or CE,FDA,NMPA notified bodies, etc.) on regulatory filings.
・Current, working knowledge of medical device regulations and/or biologics regulations, i.e.US FDA 21 CFR, European regulations (i.e. MDD/MDR), Health Canada, 21 CFR 820, ISO13485, MDSAP, other global regulations and standards as relates to submissions to governmental and other agencies, as well as Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
・Ability to assess regulatory impact of design and/or manufacturing changes.
・Draft and/or evaluate regulatory SOP’s and WI’s.
・Prepare white papers detailing current Regulatory topics.
・Research laws and regulations for international countries, as needed.
・Serve as an expert and able to professionally negotiate strategies directly with government entities (e.g. PMDA and /or CE,FDA, NMPA, notified bodies, etc.) on regulatory filings at the
・Function as an expert in US and international medical device regulations, combination product regulations and/or biologics regulations, i.e. US FDA 21 CFR, European regulations(i.e. MDD/MDR), Health Canada, 21 CFR 820, ISO 13485, MDSAP, other global regulations and standards as relalates to submissions to governmental and other agencies, as well as Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
・Work with client and/or test houses to develop pre-clinical test plans/protocols.
・Develop animal study protocols in conjunction with client and animal lab personnel.
■Qualifications and Skills
Requires a minimum of
・Bachelor’s degree or equivalent experience in a related field, with a minimum of 7 years of relevant experience; and
・Regulatory experience in the medical device industry, both Japan （PMDA, Notofied Body) and international (FDA, Notified Body etc.).
・Strong written, verbal communication and interpersonal skills.
・Problem solving and/or troubleshooting experience.
・Good tracking record of completing the projects and acquire approval i.e. PMDA Shonin approval, FDA 510 clearance etc.
・Fluency in English and local language, if different, required.
・Knowledge of and experience with Microsoft Office
・Write and review complex documents