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Senior Regulatory Affairs Project Manager
2 months ago
Job Overview
The Senior Regulatory Affairs Project Manager is accountable for overseeing regulatory affairs initiatives linked to West's extensive range of medical devices, combination products, software as a medical device (SaMD), and packaging elements. This role necessitates collaboration with various teams and leadership of the regulatory group throughout all project stages to facilitate submissions, including Premarket Notifications, Technical Documentation in accordance with EU MDR (Medical Device Regulation), and Master Files (DMF/MAF) related to pharmaceutical partners' NDAs (New Drug Applications), ANDAs (Abbreviated New Drug Applications), and/or BLAs (Biologics License Applications). The incumbent must stay informed about current international regulations, guidelines, and policies relevant to West's offerings. This position also involves providing regulatory insights and updates to both internal and external stakeholders, adhering to established regulatory strategies.
Key Responsibilities:
- Serve as the lead for cross-functional regulatory projects throughout the entire lifecycle (Pre-Submission, Submission, Post-Submission, and Post-Approval), ensuring the timely achievement of project goals aligned with the regulatory affairs team's priorities.
- Oversee the preparation, evaluation, and submission of intricate global regulatory documents, responses to information requests, change notifications, and post-market compliance reports.
- Independently assess and monitor regulatory project advancement against set milestones, create integrated timelines, and proactively identify and escalate project risks or technical gaps to leadership.
- Engage in regulatory planning and assist in formulating global regulatory strategies, taking into account the latest guidance documents and current standards/regulations.
- Collaborate with regulatory leads, project managers, and subject matter experts across R&D, quality assurance, clinical affairs, labeling, and other areas to synchronize deliverables for global submissions, establish key regulatory positions, and ensure compliance in product development and lifecycle management activities.
- Develop and implement action plans for addressing regulatory risks and resolving submission issues. Maintain logs of issues and manage risk mitigation efforts throughout the project lifecycle.
- Create regulatory project charters and maintain dashboards that provide essential performance metrics and other critical information to stakeholders.
- Prepare for and manage regulatory audits and inspections by authorities, ensuring that all findings or nonconformities are promptly addressed and reported.
- Stay updated on evolving regulations, guidelines, and industry trends to guide regulatory actions.
- Assist in establishing and maintaining the infrastructure, tools, and procedures for the Regulatory Project Management team.
Basic Qualifications:
- Education: Bachelor's or Master's degree in a scientific, engineering, or related field.
- Experience: Bachelor's degree with 5 years of experience; or Master's/PhD with 2-3 years of experience in the development, scale-up, and registration of regulated medical devices and combination products.
Preferred Skills and Qualifications:
- Strong interpersonal, communication, and organizational skills with a proven ability to work with and influence multidisciplinary teams and external industry experts.
- Demonstrated technical leadership capabilities and understanding of pharmaceutical and/or medical device operations (e.g., manufacturing, process development, analytical, quality assurance).
- Proficiency in project management software and regulatory tools.
- Proven success in regulatory submissions and interactions with regulatory bodies.
- Experience in the development and registration of regulated combination products and medical devices, with in-depth knowledge of industry-specific regulations and standards.
- Exceptional project management abilities, including planning, execution, and budget oversight.
- Fundamental understanding of Quality Management System (QMS) requirements, state-of-the-art standards (ISO 13485, ISO 14971, ISO 15223, IEC 62304, ISO 11608), 21 CFR Part 820, and CMC regulatory requirements.
- Experience in medical device lifecycle management, including change controls, device complaint investigations, CAPAs, and post-market surveillance.
- Regulatory Affairs Certification (R.A.C) and/or Project Management Professional (PMP) Certification.
Travel Requirements:
- Must be able to travel up to 5% of the time.
Physical and Mental Requirements:
- Ability to work independently in a fast-paced, dynamic environment while adhering to multiple time-sensitive commitments.
- Sedentary work environment: exerting up to 10lbs/4kgs of force occasionally, and/or negligible force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary roles involve sitting most of the time.
- Ability to comprehend principles of math, science, engineering, and medical device usage.
- Ability to handle technical reports, drawings, specifications, regulatory, and quality documentation with a high degree of confidentiality.
- Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
- Ability to review, collate, describe, and summarize scientific and technical data.
- Ability to organize complex information and synthesize pieces of information to form general rules or conclusions.
- Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate course of action.
- Ability to assess, plan, schedule, and manage multiple long-term and short-term projects, tasks, responsibilities, and/or priorities concurrently with several parallel deliverables and execute deliverables within timeline commitments.
- Ability to be an effective team member and collaborate well with others in a team environment on cross-functional and/or matrix teams.
- Ability to comprehend and apply language skills to the degree required to perform the job based on the job requirements listed above.
- Ability to write and record data and information as required by procedures.
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