REGULATORY AFFAIRS SPECIALIST

Job Summary Has direct responsibility for ensuring regulatory compliance with market registration and codification of the products in Portugal and providing support to the Tender and Sales departments in order to comply with customer and other applicable requests.
Key Accountabilities 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 established in the procedures adopted by the Company.
Ensures proper market registration and codification of the new products and materials in Portugal and also renews and keeps up-to-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.
Declarations of Conformity/EC Certificates, 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 up-to-date in the Information Systems of the Company, regarding the documented information of the products marketed in Portugal.
Assures correct back-up of the activities of the Qualified Person, when necessary, including activities related to complaints and the vigilance system.
Ensures compliance with Werfen Code of Ethics.
Other duties as requested; including, but not limited to, participating in special Projects related with regulatory/legislative demands.
Networking/Key relationships This position requires cooperating with Business Units, Tender Office, Sales and Marketing, Warehouse and Supply Chain Office, Regulatory contact of represented companies/manufacturers, national competent authorities and customer contacts.
Minimum Knowledge & Experience required for the position.
Education.
Degree in a Science, Engineering or similar.
Experience.
Minimum 3 years of work experience in a Regulatory Affairs Department within the healthcare sector or pharmaceutical sector.
Additional Skills/Knowledge.
Knowledge of Medical Devices and In Vitro Diagnostics Medical Devices legislation and product requirements in Portugal.
In particular, knowledge of product registration process in Infarmed.
Basic knowledge of quality management systems and ISO standards.
Strong computer skills including Word, Excel, PowerPoint, ERP systems (SAP desirable).
Awareness of the requirements of relevant local and EU regulations.
Language.
Portuguese and English (Spanished desirable).
Skills & Capabilities.
The ideal candidate for this position will exhibit the following skills and competencies.
Strong willingness to comply with regulations and procedures  Teamwork and collaboration Critical thinking Attention to detail Delivers results Customer focus Relationship management Flexibility and adaptability to a fast-changing environment Travel requirements.
Not applicable