Requisition ID: 48797 Title: Team Lead, Regulatory Affairs - Medical Writer Division: Arthrex, Inc. (US01) Location: INC- Naples FL (US08)
As the Team Lead for the Regulatory Affairs Medical Writing function you will lead a team of direct reports in the development and execution of generating medical writing deliverables in support of EU MDR compliance. You will have the primary responsibility of guiding a team in developing Clinical Evaluation Plans, Clinical Evaluation Reports, Post Market Surveillance Plans, Post Market Surveillance Reports, Periodic Safety Update Reports, Post-market Clinical Follow-up Plans, Post-market Clinical Follow-up Reports, and Summary of Safety and Clinical Performance documents and collaborating on a number of other clinical and regulatory documents.
Essential Duties and Responsibilities:
- Manage day-to-day activities and processes to ensure issues are appropriately evaluated and resolved.
- Manage direct reports to meet or exceed defined targets, KPIs, performance objectives, etc.
- Create and manage detailed project schedule for Clinical Evaluation Plans, Clinical Evaluation Reports, Post Market Surveillance Plans, Post Market Surveillance Reports, Periodic Safety Update Reports, Post-market Clinical Follow-up Plans, Post-market Clinical Follow-up Reports, and Summary of Safety and Clinical Performance documents.
- Develop and Write Clinical Evaluation Plans, Clinical Evaluation Reports, Post Market Surveillance Plans, Post Market Surveillance Reports, Periodic Safety Update Reports, Post-market Clinical Follow-up Plans, and Summary of Safety and Clinical Performance documents in accordance with European Union guidance and internal procedures using relevant information compiled from clinical research, peer reviewed publications, risk management files and post market data.
- Combine understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices.
- Recruit, select and develop talent within team to increase performance. Actively address performance issues of team.
- Support direct reports in managing workload within assigned projects through efficient resource utilization and effectively communicate cross-functionally.
- Reports to manager the status of projects with emphasis on reporting challenges and results.
- Identify and communicates information to manager which would affect regulatory compliance.
- Contributes to the development of internal procedures, templates, style guides and departmental continuous improvement initiatives.
- Independently performs, as well as direct and monitor the work of Direct Reports, Consultants and Contractors, for the below duties and responsibilities:
- Perform formal literature searches and critical review literature and data analysis from clinical investigations and succinctly summarize scientific content and write risk versus benefit analyses and conclusions in accordance with European Union guidance.
- Participate in post-market surveillance activities by conducting routine systematic literature reviews (e.g. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups.
- Ensure the Clinical Evaluation files and other documents are linked to the appropriate Quality Systems and Regulatory documents (e.g. Risk Management, PMS, etc.) for consistency and accessibility.
- Collaborate with Clinical Study Managers in the preparation and development of study protocols and data collection strategies to aid regulatory commitments and marketing claims; make recommendations for statistical analyses.
- Analyze clinical trial data throughout studies as it relates to PMCF requirements; make recommendations for any modifications to the plans or protocols.
- Serve as a SME on product development teams for the generation of clinical plan.
- Represent the regulatory-clinical team cross-functionally for activities including change control, risk management, and collateral review.
- Proactively partner with cross functional business partners such as Medical Affairs, Post-Market Surveillance, Quality, R&D, Regulatory Affairs, others relating to the Clinical Evaluation process and to verify and approve content of final Clinical Evaluation documentation.
- Supporting and, at times, acting as a subject matter authority during audits and inspections pertaining to Clinical Evaluation processes, plans and reports.
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
- Bachelor's Degree required; emphasis in health/science-related field preferred.
- A Master's or Ph.D. or other higher degree in health-related field (RN, BSN, BPharm/MD/MPH) preferred.
- Regulatory Affairs (RAC) preferred.
- 7 years of experience in functions such as clinical, regulatory, medical affairs, quality, research, and medical safety where scientific/medical writing was needed.
- Experience in medical device industry required.
- Experience evaluating or drafting CERs required.
- Experience conducting literature searches and literature reviews.
- Experience preparing clinical sections of regulatory documents for FDA and/or international agencies required.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
- Subject Matter Expert for MDR clinical requirements. Advanced knowledge, understanding and application of MDR or other regulatory agency regulations, guidance, policies, and procedures pertinent to medical device development, including 21 CFR 820 and ISO 13485 requirements. ISO 14971 a plus.
- Advanced knowledge of clinical and regulatory regulations.
- Advanced knowledge of clinical trial strategy, study design and sponsor reporting requirements.
- Broad based technical knowledge in diverse areas of business (e.g. R&D, Operations, QA, Marketing, Clinical research etc.) and their relationship to organizational activities.
- Comprehensive understanding of orthopedic/technical/engineering/medical terminology.
- Knowledge of overall business environment, orthopedic industry and marketplace. Business fluency in multiple geographies and business cultures.
- Advanced written, verbal and listening communication skills (internal/external and up/across/down)
- Excellent skills in strategic and technical thinking, problem-solving, writing, and editing.
- Comprehensive approach and meticulous attention to detail.
- Ability to comprehend principles of engineering, physiology and medical device use.
- Ability to handle master documents, drawings, specifications, regulatory and clinical documentation with a high degree of confidentiality.
- Ability to research, read, analyze, and interpret clinical and 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 (includes finding a relationship among seemingly unrelated events) to produce answers that make sense.
- 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 matrixed teams.
- Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures.
- Ability to build strong relationships both internally and externally.
- Preference to work in a fast-paced environment.
Machine, Tools, and/or Equipment Skills:
Proficiency in the use of Personal Computers and computer programs, particularly SAP, Microsoft Office Suite; Excel, Word, PowerPoint and Adobe Acrobat (or equivalents if changed by the Company) as well as ability to navigate Workfront, LMS, Documentum, and other local and proprietary systems.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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