REGULATORY AFFAIRS & QUALITY ASSURANCE SPECIALIST Lisboa

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

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REGULATORY AFFAIRS & QUALITY ASSURANCE SPECIALIST

Client: Luso
Palex

Location: Portugal

Job Category: Other

EU work permit required: Yes

Job Reference: 5f0677b7cb46

Job Views: 5

Posted: 03. 03. 2025

Expiry Date: 17. 04. 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;
• Aware 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.