Quality and Regulatory Affairs (QA/RA) Trainee The Quality and Regulatory Affairs (QA/RA) Trainee supports the execution of pre
and/or post market regulatory affairs departmental functions, including, but not limited to,
assisting in the preparation of documentation and information required to place and to
keep products on the market: regulatory submissions, licensing and registrations,
assisting in the execution of post market surveillance activities: complaint evaluations,
product corrections, removals and recalls.
Key Accountabilities
Assists in efforts to ensure the company is properly registered and in compliance
with applicable national and international regulations.
Collaborates in efforts to prepare and submit regulatory submittals for market
clearance, licensing, registration and legalization.
Supports the execution of global field corrective actions/recalls.
Assists in interactions regarding regulatory affairs with all functional areas of the
company as required, including senior management, mainly, providing support to the
Tender and Sales departments to comply with customer's requests, including but not
limited to: Declarations of Conformity/EC Certificates, Instructions for Use and
Labelling, Lot Certificates and Safety Data Sheets.
Ensures correct upload and maintenance up to date in the Information Systems of
the Company, regarding the documented information of the tasks under his/her
responsibility.
Ensures compliance with Werfen Code of Ethics.
Networking/Key relationships
This position may require cooperating with the Tender Office, Sales and Marketing
Office, Service Office, Supply Chain Office, Regulatory contact of represented
companies/manufacturers and customer contacts.
Minimum Knowledge & Experience required for the position
Education: Degree in a science, finance and administration discipline or equivalent
Experience: Not required.
Additional Skills/Knowledge:
o Awareness of the requirements of relevant local and international regulations.
o Strong computer skills required: MS Office, ability to use an enterprise
resource planning system (ERP) and other regulatory software tools.
o Language: Spanish and English.
Skills & Capabilities
The ideal candidate for this position will exhibit the following skills and
o Strong willingness to comply with regulations and procedures
o Excellent written and verbal communication skills
o Teamwork and collaboration
o Delivers results
o Relationship management
o Flexibility and adaptability to a fast-changing environment
Overview Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a...
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