Senior Reg Affairs - Project Manager - Wexford - Hybrid role
My client, a multinational is looking for a SeniorRegulatory Affairs candidate with excellent Project Manager experience (Hybrid role) to join their team in Enniscorthy.
In this role you will have dual site responsibility, you will ensure compliance with applicable Regulatory Requirements for all applicable territories in which devices are placed on the market as well as inputs to development of regulatory strategies and provides regulatory guidance and expertise. You will compile and communicate regulatory requirements (e.g. MDR, FDA, International, standards, etc) to support R&D, Manufacturing & Quality to ensure systems are compliant with all internal and external guidelines.
You will ideally have 5-7 years in a med device or pharma setting.
What is my client offering you?
- You will have an amazing opportunity to join a successful and expanding team.
- Excellent salary and benefits package
- Excellent opportunities for career progression and advancement.
Key Responsibilities include:
- Reviews and approves the project documentation (design reports, labelling, etc.).
- Develops tactics supporting regulatory notifications and submissions to minimize the market supply impact as a result of device changes.
- Participates in product development/sustaining teams as required to ensure that the product is in compliance with all internal and external regulatory requirements.
- Preparation and submission of dossiers to regulatory authorities for CE mark and FDA approval
- Minimum of degree in Life Sciences or Engineering or equivalent
- Have worked with regulatory submissions with exposure to implantable devices.
- Knowledge and experience on EU MDR and standards (ISO 13485, ISO 14971) is a must, knowledge of FDA and international regulatory requirements is a plus.
- Regulatory Affairs / Quality Systems experience in the Medical Device or pharmaceutical industry
- Good regulatory knowledge, e.g. guidelines, policies, principles and requirements of applicable product laws/standards
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