Regulatory Affairs Specialist

• Support the Wound Management Regulatory Affairs team
• Provide regulatory support for a diverse line of absorbable and non-absorbable, coated and uncoated sutures
• Support sustaining globalization, international submissions, commercial support, manufacturing support, and systems improvement
• Coordinate and prepare document packages for regulatory submissions, internal audits, and inspections
• Lead or compile materials required for submissions, license renewals, and annual registrations
• Recommend labeling, manufacturing, marketing, and clinical protocol changes for regulatory compliance
• Monitor and improve tracking and control systems
• Keep abreast of regulatory procedures and changes
• Direct interaction with regulatory agencies on defined matters
• Recommend strategies for earliest possible approval of clinical trial applications

• Bachelor’s degree required
• Minimum of 2 years of relevant experience, or advanced degree with a minimum of 0 years of relevant experience
• For Baccalaureate degrees earned outside of the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
• Unrestricted U.S. work authorization required at the time of hire and for the duration of employment
• Experience with U.S. FDA and international regulatory requirements for medical devices
• Familiarity with EU MDR, MDD, ISO 13485, ISO 14971, and related standards
• Experience supporting regulatory submissions, audits, or inspections
• Strong written and verbal communication skills
• Strong organizational skills and ability to manage multiple priorities
• Experience collaborating in a cross-functional, fast-paced environment
• Familiarity with medical device product development or lifecycle management
• RAC certification or progress toward certification
• Experience working with Notified Bodies or global regulatory agencies

Demonstrates expertise in regulatory affairs for medical devices, including experience with U.S. FDA and international regulatory requirements. Proficient in managing regulatory submissions, audits, and inspections while ensuring compliance with relevant standards such as EU MDR and ISO 13485.

• Regulatory Submissions
• U.S. FDA Experience
• EU MDR Familiarity
• RAC Certification
• Cross-Functional Collaboration

• Regulatory Compliance
• Document Preparation
• Clinical Protocol Changes
• Tracking and Control Systems
• Medical Device Lifecycle Management

• Strong Written Communication
• Strong Verbal Communication
• Organizational Skills
• Ability to Manage Multiple Priorities

• RAC Certification

• Absorbable Sutures
• Non-Absorbable Sutures
• Internal Audits
• Notified Bodies
• Global Regulatory Agencies