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Sr. Regulatory Affairs Project Management Specialist

2 months ago

Exton, United States IntePros Full time

IntePros is currently looking for a Sr. Regulatory Affairs Project Management Specialist to join one of our growing medical device/manufacturing clients. The Sr. Regulatory Affairs Project Management Specialist is responsible for management of regulatory affairs projects associated with client’s global portfolio of medical devices, combination products, SaMDs, and packaging components. The RPM will work collaboratively with cross functional teams and lead the regulatory team through all project phases to support submissions including Premarket Notifications, Technical Documentations under EU MDR (Medical Device Regulation), and Master Files (DMF/MAF) associated with pharmaceutical partner’s NDAs (New Drug Applications), ANDAs (abbreviated new drug applications), and/or BLAs (Biologics License Applications). They should maintain knowledge of current international regulations/guidelines/policies applicable to client’s products and services. This position includes providing regulatory guidance and updates to internal and external stakeholders in line with defined regulatory plans.



Sr. Regulatory Affairs Project Management Specialist Responsibilities:

  • Act as the RPM lead on cross-functional regulatory projects across the entire lifecycle (Pre-Sub, Sub, Post-Sub, and Post-Approval) and ensure timely execution of project objectives in line with regulatory affairs (RA) team’s priorities.
  • Manage the preparation, review, and submission of complex global regulatory filings, information request responses, change notifications, and post-market surveillance reports/compliance reports.
  • Independently analyze and track regulatory project progress against pre-defined milestones, develop integrated timelines, and be proactive in identifying and escalating project risks/technical gaps to leadership teams.
  • Participate in regulatory planning and support the development of global regulatory strategies, with consideration of latest guidance documents and current state-of-art standards/regulations.
  • Collaborate with regulatory lead(s), cross-functional project manager(s) and SMEs (Subject Matter Experts) in R&D, quality assurance, clinical affairs, labeling, and more to align on deliverables for global submissions, establish key regulatory positions, and to ensure product development and lifecycle management activities are performed in compliance with applicable regulatory requirements.
  • Present and implement action plan(s) for regulatory risk remediation and submission issue resolution. Maintain issue logs/register(s) and manage risk mitigation efforts for the entire lifecycle of the project.
  • Generate regulatory project charter(s) and maintain project dashboard(s) that deliver informative performance metrics and other critical information to stakeholders.
  • Prepare for and manage regulatory audits and inspections by authorities, ensuring all findings or nonconformities are timely addressed and submitted to authorities.
  • Remain current on evolving regulations, guidelines, and industry trends to inform regulatory actions.
  • Assist in the establishment and maintenance of infrastructure tools, procedures, systems for Regulatory Project Management (RPM) team.

Sr. Regulatory Affairs Project Management Specialist Basic Qualifications:

  • Education: Bachelor's or Master’s degree in science, engineering, or related discipline
  • Experience: Bachelor’s with 5 years; or Master’s/PhD degree with 2-3 years’ experience in the area of development, scale-up and registration of regulated medical devices and combination products.

Sr. Regulatory Affairs Project Management Specialist Preferred Skills:

  • Excellent interpersonal, communication and organizational skills with a proven record of working with and influencing multi-disciplinary teams and external industry experts.
  • Possesses technical leadership skills, as well as demonstrated understanding of pharmaceutical and/or medical device operations (e.g., manufacturing, process development, analytical, quality assurance).
  • Proficiency in using project management software and regulatory tools.
  • Proven track record of successful regulatory submissions and interactions with regulatory authorities.
  • Experience in regulated combination product and medical device development, registration of Class I and Class II, Class III medical devices, and profound knowledge of industry-specific regulations and standards.
  • Exceptional project management skills, including planning, execution, and budget management.
  • Fundamental knowledge of Quality Management System (QMS) requirements, State-of-art standards (ISO 13485, ISO 14971, ISO 15223, IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements.
  • Experience in medical device life-cycle 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 with requirement to adhere to multiple time-sensitive commitments.
  • Sedentary environment: exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met
  • Ability to comprehend principles of math, science, engineering, and medical device use.
  • 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 combine 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 one.
  • Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
  • Ability to be an effective team member and work 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 upon the job requirements listed above.
  • Ability to write and record data and information as required by procedures.