Senior International Regulatory Affairs Specialist, EMEA
Artex Risk Solutions
full-time
Posted on:
Location Type: Office
Location: Naples • Florida • United States
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Job Level
About the role
- 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.
Requirements
- Bachelor's Degree required
- 5+ years relative experience
- Experience supporting medical device registrations/licenses/submissions and quality audit requests applicable to assigned regional area.
Benefits
- 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 Parental Leave
- Paid Time Off
- Volunteer PTO
- Employee Assistance Provider (EAP)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory documentationtechnical reviewdata analysisstandard operating proceduresquality assuranceinternational regulationsmedical device registrationslicense renewalsaudit participationemployee training
Soft Skills
communicationproblem-solvingcollaborationattention to detailorganizational skillsfeedback provisionadaptabilitysolution-oriented
Certifications
Bachelor's Degree