International Regulatory Affairs Specialist - APAC

Arthrex; Naples (FL); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Company-Provided Life Insurance

401(k) Retirement Plan

Annual Bonus

Paid Time Off

Onsite Medical Clinics

Onsite Lunch

Tuition Reimbursement Program

Job summary

Arthrex, Inc. in Naples, FL is seeking an International Regulatory Affairs Specialist - APAC to support global registrations for leading medical devices. The role requires a Bachelor’s degree and 2+ years of RA experience for Specialist II, or 5+ years for Senior.

You will collaborate across Engineering, R&D, Manufacturing, and QA to prepare regulatory submissions and maintain approvals. Join a team focused on helping surgeons treat their patients better, with opportunities for international

Qualifications

• Bachelor's degree required.
• RA Specialist II - 2+ years relevant RA experience supporting medical device registrations/licenses/submissions and quality audit requests.
• RA Specialist Senior - 5+ years relevant RA experience supporting registrations/licenses/submissions and quality audit requests.

Responsibilities

• Research and respond to inquiries to facilitate new product registrations, license renewals, re-registrations, design change notifications, manufacturing and labeling changes, customs requests, and international marketing bids.
• Coordinate with Engineering, R&D, Manufacturing, Quality Assurance, and other departments to collect technical information for regulatory documents.
• Provide technical review of data or reports for regulatory agencies to ensure accuracy and compliance.
• Manage and process Certificates to Foreign Government, Certificates of Manufacture and Free Sale, and Certificates of Exportability.
• Develop and conduct employee training for International Regulatory Affairs.

Skills

Regulatory affairs

Medical devices

Technical writing

Cross-functional collaboration

Education

Bachelor's degree

Tools

SAP

Excel

Word

PowerPoint

Adobe Acrobat

Job description

Research & Development - Naples, FL, US, 34108

International Regulatory Affairs Specialist - APAC

Title: International Regulatory Affairs Specialist - APAC

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 Regulatory Affairs Specialist II, and RA Specialist Senior for our global headquarters in Naples, Fl. The ideal candidate for Specialist II will have a Bachelor's degree and 2+ years relevant RA experience, preferrably in the medical device industry. The Senior Specialist will have a Bachelor's degree and 5 years relevant experience. The International Regulatory Affairs Specialists advance Arthrex’s global market access by providing technical support to Arthrex subsidiaries and distributors to achieve and/or maintain regulatory and quality approval/clearance/registration/licensure/certifications for Arthrex’s medical devices in the most efficient and least burdensome approach to meet business needs while maintaining compliance. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• Research and respond to inquiries from Arthrex subsidiaries and distributors to facilitate new product registrations, license renewals, re-registrations, design change notifications, manufacturing and labeling changes, customs requests, international marketing bid/tenders and to support quality tasks related to foreign manufacturer registrations.
• Coordinate with Engineering, R&D, Manufacturing, Quality Assurance, and other applicable departments to collect technical information and data associated with the preparation of international regulatory documents to support Arthrex subsidiaries and distributors new product registrations, license renewals, re-registrations, design change notifications, manufacturing and labeling changes, customs requests and international marketing bid/tenders.
• Provide technical review of data or reports to be provided to regulatory agencies to ensure scientific rigor, accuracy, clarity of presentation, completeness, consistency, and conformance to regulations and guidelines and internal policies/procedures to ensure all data and information is truthful, accurate and verifiable against source documentation to confirm compliance and traceability.
• Manage and process requests for Certificates to Foreign Government, Certificates of Manufacture and Free Sale, and Certificates of Exportability.
• Provide feedback and on-going support to Arthrex subsidiaries and distributors to resolve (potential) regulatory issues and inquiries from regulatory agencies - offering solutions, as applicable.
• Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products.
• Partner with in-country Regulatory and Quality staff to identify international regulations, guidances, policies, and/or procedures for changes and ensure change notification to Regulatory leadership and appropriate stakeholders.
• Recommend changes to company procedures in response to changes in regulations, guidances and/or standards.
• Write or update standard operating procedures, work instructions, or policies.
• Participate in internal or external audits.
• Develop and/or conduct employee training for International Regulatory Affairs.

Education and Experience:

• Bachelor's degree required
• RA Specialist II - 2+ years relevant experience supporting medical device registrations/licenses/submissions and quality audit requests applicable to assigned area.
• RA Specialist Senior - 5+ years relevant experience supporting registrations/licenses/submissions and quality audit requests applicable to assigned area.

Reasoning Ability:

Ability to identify and define problems, collect data, analyze established facts, draw valid conclusions, 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 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 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 utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one. Ability to actively learn; understanding the implications of new information for both current and future problem-solving and decision-making.

Abilities Requirements:

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 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.

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).

Language and Communication Skills:

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.

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Time Off
• Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.

Chers visiteurs,
Les informations présentées sur ce site, sont exclusivement réservées aux professionnels de santé exerçant sur le territoire français.
Dear Visitors,
The information on this website is intended exclusively for healthcare professionals practicing in France.