Senior Regulatory Affairs Specialist (Onsite/Remote)

Job description

Description Represents the Regulatory Affairs department in assigned project teams and provides regulatory input in accordance with established timelines to meet corporate objectives. Develops and executes sound regulatory strategies to support business goals. Oversees and ensures compliance with state, federal, and international medical device regulations and overall regulatory departmental objectives for new and existing products. ESSENTIAL AND OTHER DUTIES AND RESPONSIBILITIES: Essential Duties and Responsibilities - Represents RA department in assigned project meetings and provides regulatory guidance to ensure adherence with global regulatory requirements as appropriate. - In conjunction with project teams and international partners, evaluates possible pathways to marketing authorization and recommends pathway that appropriately weighs the probability of success with potential risks to the business. Develops and executes sound regulatory strategies to support business goals. - Independently assesses product and manufacturing changes and develops well-justified regulatory assessments for each global market. - Reviews and approves document change orders, advertising and promotio...