REGULATORY AFFAIRS & QUALITY ASSURANCE SPECIALIST Carnaxide

REGULATORY AFFAIRS & QUALITY ASSURANCE SPECIALIST
Lisboa
Carnaxide, Lisboa, Portugal

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Client:

Luso
Palex

Location:

Job Category:

Other

EU work permit required:

Yes

Job Reference:

5f0677b7cb46

Job Views:

4

Posted:

14. 02. 2025

Expiry Date:

31. 03. 2025

Job Description:

Palex Portugal, a leading company in the management and distribution of innovative hospital and research solutions, is recruiting a Regulatory Affairs & Quality Assurance Specialist.

Main Responsibilities:

• Ensures correct management and approval of new products and materials requests upon documentary verification, including but not limited to: Declaration of Conformity/ EC Certificate, Instructions for use and labelling, and other applicable documentation.
• Ensures proper market registration and codification of the new products and materials in Portugal and also renews and keeps
  -
  - date current registrations and codifications, following the procedures established by the Competent Authorities and adopted by the Company.
• Provides support to the Tender and Sales departments to comply with customer's requests, including but not limited to: Declaration of Conformity/ EC Certificate, Instructions for use and labelling, Lot Certificates and Safety Data Sheets.
• Provides support to Competent Authority to comply with legal and regulatory requests.
• Ensures correct upload and maintenance
  -
  - date in the Information Systems of the Company, regarding the documented information of the products marketed in Portugal.
• Assures correct
  - up of the activities of the Qualified Person, when necessary, including activities related to complaints and the vigilance system.
• Ensures compliance with company Code of Ethics.
• Other duties as requested, including, but not limited to participating in special Projects related with regulatory/legislative demands.

Knowledge & Experience:

• Degree in Science, Engineering or similar.
• Minimum of 3 years' experience in a similar role.
• Experience in a multinational context (preferred).
• Knowledge of Medical Devices and In Vitro Medical Devices legislation and product requirements in Portugal, in particular, knowledge of product registration process in Infarmed.
• Strong computer skills including MS-Office and ERP systems (preferably SAP).
• Basic knowledge of quality management systems and ISO Standards (9001, 14001).
• Good knowledge of English (preferred) and Spanish.
• Awareness of the requirements of relevant local and EU regulations.

Skills & Capabilities:

• Strong willingness to comply with regulations and procedures.
• Teamwork and collaboration.
• Critical thinking.
• Flexibility and adaptability to a
  - changing environment.

What we offer:

• Integration into an expanding multinational company.
• Collaborative and dynamic working environment.
• Opportunities for skills development and ongoing training.
• Basic salary + Meal allowance + Variable bonus according to performance.
• Social benefits in force in the company: Health Insurance, Life Insurance, among others.