Requisition ID: 48794 Title: Team Lead, International Regulatory Affairs Division: Arthrex, Inc. (US01) Location: INC- Naples FL (US08)
Supervise the daily operations of an International Regulatory Affairs Facilitation Team for a region to support timely regulatory registration in compliance with all applicable regulations and guidance for the commercial distribution of all products within the region.
Essential Duties and Responsibilities:
- Supervise the Regulatory Affairs Facilitation Team for the assigned region.
- Ensure the timely preparation and processing of documentation required for product registration of products in applicable markets.
- Ensure the timely processing of generally required global registration documents such as Certificate to Foreign Government (CFGs), Apostille and Legalizations, and country specific requirements as regulations demand for applicable markets
- Ensure timely product shipment release for the region.
- Collaborating and communicating with Business Unit (BU) partners and regional partners to ensure efficient and timely global product registrations and release.
- Work collaboratively with other RA staff to ensure consistency of RA inputs and strategies.
- Prepare submission related documents for new product introductions, license renewals and product changes in the region.
- Interact with the regulatory affairs teams in country.
- Work with international regulatory staff and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
- Review Change Orders and assess regulatory impact of product changes on international regulatory licenses and submissions.
- Research and respond to regulatory questions received from other division functions and outside sources (i.e., distributors, customs issues, etc.).
- Manage key internal systems, databases, and records.
- Maintain proficiency in regulatory requirements in the assigned region; monitor changes to regulatory requirements and keep the relevant team and managers informed about potential impact.
- Follow all work/quality procedures to ensure quality system compliance and high-quality work
- Contribute to and maintain regulatory affairs department standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
- Support Regulatory Operations activities such as Global UDI, Product information Management (PIM) and Regulatory Information Management (RIM) systems.
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.
- 7 years direct experience in a Medical Device Regulatory Affairs role required.
- Prior successful experience in Regulatory Affairs supervisory role preferred.
- Experience in orthopedic medical device industry preferred.
- Experience in independently preparing regulatory documentation required.
- Experience with applicable regional regulatory agencies submission process and regulatory strategy for medical devices required.
- 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 regional regulatory submission matters. Advanced knowledge, understanding and application of regional 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.
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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