Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Manager, Regulatory Affairs – EMEA. The position is based at the Arthrex world headquarters campus in Naples, Florida. Relocation assistance may be available along with Arthrex’s exceptional employee benefits and work culture. Join our talented team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better™.
Main Objective:
Drive strategic regulatory activities for EMEA and manage technical file activities related to EU MDR/UKDS compliance.
Essential Duties and Responsibilities:
Manage day-to-day regulatory activities and processes to ensure issues are appropriately evaluated and resolved.
Ensure MDR/UKDS commitments are met and communicated in a timely manner.
Manage the activities related to the updating and review of technical documentation for UKCA/CE marking, including Technical Files/Design Dossiers and Clinical Evaluation Reports.
Responsible for maintaining up-to date product registrations in EMEA.
Acts as a liaison between Arthrex and the Notified Body.
Manage Notified Bodies audit scheduling and coordination.
Lead Regulatory audits and support Quality audits conducted by notified bodies.
Review and manage the coordination of Arthrex’s response to request for information from Notified Bodies and Competent Authorities.
Define targets, KPIs, performance objectives, etc., for individuals with a functional role, and manage direct reports to meet or exceed these targets.
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.
Establish meaningful metrics for regulatory and compliance activities and produce status reports for leadership.
Manage project plans, resolve issues, and identify project risks.
Manage the facilitation of information to support regulatory activities in Eastern Europe and the Middle East.
Monitor changes in EMEA RA environment and communicates changes to RA leadership and manage RA plans as necessary to ensure organization-wide compliance.
Establish and maintain EMEA related training program for Specialists.
Assist Quality Assurance Department in maintaining the Quality System compliance program.
Participates in product safety alert/recall policy development and coordinates recalls.
Incidental Duties:
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, preferably in Life Sciences or Engineering.
Advanced Degree (MS, ME, MBA) preferred.
Regulatory Affairs (RAC) preferred.
10 years direct experience in a Medical Device Regulatory Affairs role required.
5 years successful experience in Regulatory Affairs management role.
Experience in people, project or process management required.
Experience in orthopedic medical device industry preferred.
Experience in independently preparing technical files and design dossiers required.
Experience with MDD/MDR submission process and regulatory strategy for MDD/MDR Class I/II/III medical devices required, other regions/geographies a plus.
Experience in providing strategic advice on integrated regulatory development plans and executing the regulatory strategy for product development required.
Experience in determination of appropriate regulatory requirements for new products and product changes.
Experience in reviewing and approving product labels and promotional/advertising materials required.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Subject Matter Expert for MDR regulatory submission matters.
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.
Knowledge of regulatory requirements for promotional materials (marketing collateral).
Strong technical understanding of product life-cycle, product development process, design control and quality system and clinical evaluation report 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.
Knowledge of clinical trial strategy, study design and sponsor reporting requirements.
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 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.
Reasoning Ability:
Ability to think critically and propose multiple solutions to solve problems. Ability to identify and define problems, collect data, analyze established facts, draw valid conclusions, implant change and effectively communicate the information both verbally and in writing to a variety of audiences. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to both appropriately format and develop a clear logic trail to establish conclusions based on an understanding of factual evidence. Ability to critically think; using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. Ability to actively learn; understanding the implications of new information for both current and future problem-solving and decision-making.
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.
