Clinical & Biocompatibility Expert. Regulatory

hace 3 semanas


Barcelona provincia, España Morgan Philips Executive Search A tiempo completo

As part of the Global Regulatory Affairs Team, we offer you an exciting and responsible task in a globally operating functional area. We enable our employees to get involved in interesting tasks in a modern working environment and to grow with them, as well as to develop professionally. If you are also enthusiastic about our meaningful product portfolio, we should get to know each other.

**Responsibilities**:
Management, registration and implementation of the applicable legal requirements regarding Regulatory Affairs for products and activities developed by the company, specifically assuring compliance with MDD and MDR requirements for medical devices.

Provide regulatory input to product lifecycle planning of medical devices, focus on MDD/MDR compliance.

Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.

Participate in risk-benefit analysis for regulatory compliance pre-market.

Assist with label development and review for compliance before release.

Provide regulatory input for product recalls and recall communications.

Support in Technical File Audits.

Become the Subject Matter Expert (SME) for Biocompatibility processes.

Responsible for implementing regulatory requirements with respect to Biocompatibility.

Manage the technical documentation of medical devices under PHSA ownership and its clinical evaluation process and the files of LHSA (Legal Manufacturer) or other ones for third legal manufacturers under agreement

Assessment of Biocompatibility Requirements for new Products, Projects,Changes & Supplier Change notifications (SCNs) and ensuring the evaluation,determination, and documentation of biological safety for all products is maintained.

Coordination with external Biocompatibility laboratories on testing required and compilation of requirements to conduct same for example: samples, quotes,critical review of protocols and reports.

Update of Biocompatibility Assessments on ongoing basis for new testing completed and documenting per SCNs /other changes.

Guarantee the compliance of Regulatory and Biocompatibility aspects for submissions for marketing Authorisations including responding to requests from Regulators.

**What we look for**:
University degree on Engineering, Pharmacy or Biology.

Understanding of applicable guidelines and regulations, for example experience with ISO 10993.

Strong knowledge of medical device regulations, in focus MDD and MDR legal requirements expertise.

Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.

Minimum 1-3 years of experience in a regulated industry in a similar role.

Very good knowledge of Spanish and English written and spoken.



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