Regulatory Affairs Specialist

Discover International are working with one of the fastest growing Radiopharma companies in the US looking to add to their expanding team looking for a Regulatory Affairs Specialist with a strong Radiopharmaceutical background on a Contract basis with the potential to become permanent later on.

Essential Functions

• Develop and successfully implement regional regulatory strategies for new and sustaining products/features that result in device approval.
• Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
• Provide strategic regional regulatory perspective during the development, review, and approval of internal and external documentation to support the development and commercialization of assigned product(s).
• Work with RA regional and product teams to ensure that regulatory requirements are appropriately considered and accounted for in programs and projects.
• Author and prepare submittals of IDEs, 510(k), PMAs, Technical Files or Design Dossiers, and other pertinent regional device applications.
• Support the Cross Functional Teams.
• Lead, support, and coordinate with internal and external resources to meet audit and compliance requirements.
• Support a culture of continuous improvement by promoting best practices, fostering innovation, and recognizing and celebrating achievements as well report on key performance indicators (KPIs) to track the progress and impact of continuous improvement efforts.

Required/Preferred Education And Experience

• Bachelor's Degree required
• Previous Experience with a strong Oncology/Radiopharma Background
• 6+ Years Early/Late Phase Regulatory Experience
• Must have experience working with the Board of Pharmacy with Compounding
• Strong FDA Knowledge
• Good Communication along with strong written skills.