Quality and Regulatory Affairs (QA/RA) TraineeThe 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 compliancewith applicable national and international regulations.
Collaborates in efforts to prepare and submit regulatory submittals for marketclearance, licensing, registration and legalization.
Supports the execution of global field corrective actions/recalls.Assists in interactions regarding regulatory affairs with all functional areas of thecompany 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 ofthe 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 ando 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...
The Project Manager (PM) is responsible for the management of New Product Development projects and other product...
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