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Senior Regulatory Affairs Expert
3 weeks ago
About the Role:
We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. In this role, you will be responsible for post-market activities for medical devices, supporting department regulatory processes and procedures, and authoring, reviewing, and submitting global registrations.
About You:
To be successful in this role, you will need to have a Bachelor's Degree in Science, Math, Engineering, or a related discipline, with +5 years of experience in medical device regulatory affairs, or a Master's Degree/PhD with 3+ years of experience. You will also need to have experience with EU MDD (93/42/EEC), EU MDR (2017/745), MDCG guidance, ISO 13485, US FDA regulations, ISO 14971, and ISO 14155, as well as experience in preparing dossiers for submission to competent authorities.
Key Responsibilities:
Support regulatory strategies for OUS medical devices and combination products, ensuring compliance with global guidelines, evolving regulations, and industry standards. Author regulatory documentation such as CIAs, Technical Documents, PMS Plans, PSURs, PMCF, and vigilance reports to Notified Bodies, EMA, and other global competent authorities. Complete global Post Market Surveillance (PMS) activities and assignments for OUS medical devices and combination products in our portfolio. Support our medical device EU importation requirements as Importer in accordance with Article 13 of MDR. Provide technical review of data and reports supporting regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation are fit for purpose. Collaborate with cross-functional teams and external stakeholders to provide guidance, issue resolution, responses to inquiries, and actions taken. Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to management, internal, and external customers. Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals. Adhere to all applicable government requirements and practices, and procedures to maintain compliance. Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as required.
Education and Experience:
Bachelor's Degree in Science, Math, Engineering, or a related discipline, with +5 years of experience in medical device regulatory affairs, or a Master's Degree/PhD with 3+ years of experience. Experience with EU MDD (93/42/EEC), EU MDR (2017/745), MDCG guidance, ISO 13485, US FDA regulations, ISO 14971, and ISO 14155. Experience in preparing dossiers for submission to competent authorities. Strong decision-making, communication, and technical writing skills. Ability to work independently and manage multiple priorities and ability to triage and manage work priorities and to follow established processes while identifying areas for process improvement in a changing environment. Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred.
Skills and Qualifications:
Established scientific and quality expertise with criteria described above. Experience in direct engagement with regulatory authorities. Regulatory compliance competency in Quality Management Systems. Knowledge of US FDA regulations and submission pathways. Familiarity with US drug-device and ROW combination product requirements. Advanced degree and/or RAC certification. 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 be flexible with changing priorities and comply with constantly changing regulatory procedures. Ability to build strong relationships both internally and externally. Ability to work in a fast-paced environment. Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures. Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).
