Sr. Regulatory Affairs Specialist

• Participate as the regulatory representative supporting cross-functional project teams.
• Draft and execute regulatory strategies for new product development and device modifications, including identifying regulatory risks, tracking timelines and submission deliverables, and establishing contingency plans.
• Support RA functional area in the review and approval of change orders, including writing letters to file where applicable.
• Obtain market clearance and approvals for class II and III medical devices, including (but not limited) to 510(k)s, IDEs, pre-submissions and PMAs.
• Create and review project deliverables for regulatory submissions.
• Interact with regulatory agency authorities for initial submission and query resolution.
• Review and approve device labelling and promotional materials.
• Support multiple projects simultaneously.
• Mentor other regulatory affairs specialists.
• Support quality system changes, improvements and audits as needed.
• Develop and maintain regulatory procedures.
• Assist in keeping the company informed of current and proposed regulatory requirements.
• Other duties as assigned.

Requirements:

• Bachelor's degree required. Bachelor's degree in life sciences, engineering, or related field preferred.
• Minimum of 5 years of experience in preparing US submissions for medical devices with bachelor's degree OR minimum 3 years of experience with advanced degree.
• Detail oriented with well-developed writing and analytical skills.
• Excellent, proven interpersonal, verbal, and written communication skills.
• Experience in Microsoft Office Suite, including Word, PowerPoint, Excel.
• Interpret subjective and complex aspects of specific regulations, with thorough understanding of multiple sets and tiers of associated regulations.