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 – Latin America. 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™.
Provide leadership, organization and coordination for key business segments, regulatory strategies, and submissions to support product launches and continuous market access.
Essential Duties and Responsibilities:
Manage day-to-day regulatory activities and processes to ensure issues are appropriately evaluated and resolved.
Define targets, KPIs, performance objectives, etc., for individuals within 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 on team.
Support direct reports in managing workload within assigned projects through efficient resource utilization and effectively communicate cross-functionally.
Develop regional regulatory strategy and aligns regulatory strategies to business objectives.
Analyze the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes.
Perform technical and scientific regulatory reviews and submissions.
Assess all requirements and potential obstacles for market access and distribution.
Critically assess the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations.
Ensure policies and procedures are in place for appropriate internal review and approval of regulatory submissions.
Lead key negotiations and interactions with regulatory authorities during all stages of the development and review process.
Prepare cross-functional teams for interactions with regulatory authorities.
Lead meetings required to drive closure of regulatory issues.
Communicate and collaborate cross-functionally to ensure corporate goals and strategies are met.
Collaborate cross-functionally to create and maintain regulatory related policy, SOPs, and work instructions.
Collaborate with international regulatory personnel to support global regulatory activities.
Monitor changes in RA environment and develop and manage programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations.
Escalation point for teams’ advertising and promotional materials approval.
Participate in regulatory or quality systems audits as necessary.
Participate in product safety alert/recall policy development.
Represent regulatory processes during internal and external audits.
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 orthopedic medical device industry preferred.
Experience in independently preparing 510(k) required.
Experience with FDA or other regulatory agency submission process and regulatory strategy for Class II 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.
Experience in people, project or process management required.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Subject Matter Expert for FDA or other regulatory agency regulatory submission matters. Advanced knowledge, understanding and application of FDA 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 lifecycle, product development process, design control and quality system 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.
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.