Employment Spot

Job Description

SENIOR REGULATORY AFFAIRS SPECIALIST The Regulatory Affairs Specialist (RAS) will report to the Director for Regulatory Affairs. A RAS plans and coordinates submissions and other document packages for tissue, medical device and combination products into worldwide regulatory agencies. The RAS works with worldwide business partners to recommend strategies for earliest possible approvals of governmental applications. He or she compiles all material required for worldwide submissions, license renewals, and annual registrations, and applies scientific principles to understanding safety and efficacy on a wide range of products. The RAS participates as regulatory team member on design and investigation projects. He or she monitors and improves tracking and control systems and keeps abreast of global regulatory procedures and changes.

• Maintain a professional stature and confidentiality.
• Follow all departmental and company policies and standard operating procedures.
• Prepare and submit, or support the submission, technical file and Design Dossiers for new and modified medical devices, tissue products and combination products through interface with worldwide regulatory agencies, notified body, physicians, consultants and internal team members.
• Participate in product development teams to insure US and other worldwide regulatory requirements are incorporated as part of the development process.
• Interpret existing and or new regulatory requirements as they relate to company products and procedures. Communicate regulatory requirements to appropriate personnel.
• Communicate any FDA, International and Industry correspondence on submissions, technical files and Design Dossiers to appropriate teams and RA management.
• Assist in post market activities. Support, R&D, Marketing and Operational Teams in regulatory assessment of proposed product changes or product transfers.
• Review product labeling and advertising materials for compliance to US and International regulations.
• Establish and maintain regulatory information systems and label systems both electronically and hard copy.
• Review and approve change management documentation
• Prepare and update US and International product listings, registrations, certificates and licenses.
• Participate on CAPA teams.
• Maintain electronic and paper files and documentation to support RA activities.
• RA and QA project and management support as directed.
• Act as company representative in developing and maintaining positive relationships with worldwide reviewers.
• Address and advise RA Management and teams on appropriate pathways to market.
• Lead Investigation and other CAPA team assignments.

Job Requirements

QUALIFICATIONS:

• Masters or other advanced degree in Life Sciences, Nursing, Medical Technology or related discipline.
• 6 years or greater RA or Clinical experience in the Medical Device, Pharmaceutical or Life Science industries.
• Must have direct experience in 510(k) submissions and extensive knowledge of FDA and/or international regulations.
• Experience in sterile, implantable products preferred.
• Bilingual in English with Asia Pacific or Spanish languages a plus.