About the Role
Responsibilities:
Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices. Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance. Assist in SOP development and review in support of next-gen product offerings. Revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions. Understand and investigate regulatory history/background of class, disease/ therapeutic context in order to assess regulatory implications for approval. Create and ensure maintenance of technical documentation (such as clinical evaluation reports, risk management reports, (k) notification) as required for obtaining and/or maintaining regulatory approval/clearance for Clien...