Regulatory Affairs Strategist
Implementing regulatory strategies is crucial for product success. As a Regulatory Affairs Strategist, you will manage regulatory submissions, assess the impact of product changes, and ensure high-quality results through guidance and mentorship.
Key Responsibilities:
* Support global regulatory strategies throughout the product lifecycle to meet market requirements.
* Collaborate with cross-functional teams to ensure regulatory requirements are incorporated into development plans and timelines.
* Oversee preparation, review, and submission of regulatory filings in the US and EU, ensuring compliance and efficiency.
* Manage resources across assigned product programs, aligning activities with departmental priorities and objectives.
* Identify potential regulatory risks and contribute to mitigation strategies to minimize threats.
Requirements:
* A minimum 7-year's experience in regulatory affairs with a degree in a Scientific or Engineering field at Level 8.
* Leadership experience demonstrated through direct management and/or mentorship/advisory capacity.
* Strong knowledge of the global regulatory landscape and experience interacting with regulatory bodies.
* Experience supporting medical devices from concept to market, including post-market activities.