Quality and Regulatory Affairs (QA/RA) Trainee

ob Summary

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

applicable experience.

• 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

competencies:

o Strong willingness to comply with regulations and procedures

o Excellent written and verbal communication skills

o Teamwork and collaboration

o Attention to detail

o Delivers results

o Customer focus

o Relationship management

o Flexibility and adaptability to a fast-changing environment

Start date: January / February 2024