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Regulatory Affairs Specialist

hace 1 mes


Barcelona, Barcelona, España Werfen A tiempo completo

Overview

The Regulatory Affairs Specialist at Werfen supports the execution of pre- and post-market regulatory affairs departmental functions, including the preparation of documentation and information required to place and keep products on the market.

About the Position

This role involves assisting in the preparation of regulatory submissions, licensing and registrations, as well as executing post-market surveillance activities such as complaint evaluations, product corrections, removals and recalls.

Key Responsibilities

  • Assist in efforts to ensure the company is properly registered and in compliance with applicable national and international regulations.
  • Collaborate in efforts to prepare and submit regulatory submittals for market clearance, licensing, registration and legalization.
  • Support the execution of global field corrective actions/recalls.
  • Assist in interactions regarding regulatory affairs with all functional areas of the company as required.
  • Ensure correct upload and maintenance of documented information in the Company's Information Systems.
  • Ensure compliance with Werfen's Code of Ethics.

Networking/Key Relationships

This position may require cooperation with various departments, including the Tender Office, Sales and Marketing Office, Service Office, Supply Chain Office, Regulatory contact of represented companies/manufacturers and customer contacts.

Minimum Requirements

Education: Degree in a science, finance and administration discipline or equivalent applicable experience.

Experience: Not required.

Additional Skills/Knowledge:

  • Awareness of the requirements of relevant local and international regulations.
  • Strong computer skills required: MS Office, ability to use an enterprise resource planning system (ERP) and other regulatory software tools.
  • Language: Spanish and English.

Skills & Capabilities

  • The ideal candidate for this position will exhibit the following skills and competencies:
  • Strong willingness to comply with regulations and procedures.
  • Excellent written and verbal communication skills.
  • Teamwork and collaboration.
  • Attention to detail.
  • Delivers results.
  • Customer focus.
  • Relationship management.
  • Flexibility and adaptability to a fast-changing environment.