Jobs

Regulatory Affairs Specialist 1

Role Overview:

The Regulatory Affairs Specialist I is responsible for supporting the development and implementation of the overall objectives and regulatory strategies that impact the introduction of new products, and the market status of existing products.

The Regulatory Affairs Specialist I will assist Regulatory Affairs management by supporting the activities and processes required to assure that products manufactured and/or distributed by Smith & Nephew Inc. are in full compliance with U.S. and all applicable international regulatory requirements.

Responsibilities:

• Prepares international dossiers for IRAMEA, LATAM and other market affiliates, to obtain and maintain global regulatory approvals of products.
• Supports regulatory strategies for new and modified products.
• Interacts with global regulatory agencies to obtain CFG, LoA, etc. as required for product registration. Provides regulatory support for global regulatory teams on international regulatory requirements. Support manufacturing changes for compliance with applicable regulations.
• Provide customer service necessary regulatory / registration information for compliance and customer requests.
• Update company databases with required information and statuses for licenses, registrations, renewals, products, and other required data.
• Update and maintain knowledge of current developments and changes to applicable laws, regulations and industry standards.
• Participates in training and development activities as required.  Support development of company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements.
• Provide support for internal and Regulatory Agency audits
• Build Quality into all aspects of job performance by maintaining compliance to all quality requirements.

Location:

Andover, MA

Requirements:

Education:

• Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline

Experience:

• 1+ year(s) Regulatory Affairs medical industry experience preferred

Competences:

• Understanding of global regulations
• Technical knowledge of medical products
• Understanding of relevant procedures, practices, and associated medical terminology
• Knowledge of product development process and design control
• Excellent research and analytical skills; detail oriented
• Ability to manage multiple projects
• Ability to work and problem solve both independently and within a team.
• Excellent written and oral communication.
• Prior experience with Product Lifecycle Management Systems and large scale document management systems a plus
• Proficiency with SAP, Microsoft Office, Adobe, internet

Travel Requirements:

<10%

Learn more here

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

Job posted: 2023-01-21