Job Description

The Senior Regulatory Affairs Associate provides regulatory guidance to assists in the development and execution of effective regulatory affairs strategies and regulatory filings for product approvals.

RESPONSIBILITIES:

• Maintains current and in-depth knowledge of FDA, and Regulatory Authority programs, policies, and other critical regulatory information
• Serves as a subject matter expert on various regulations and coordinates regulatory issue resolution using internal resources, regulatory agencies, and outside consultants as needed
• Provides guidance to assure that all regulatory submissions are planned, communicated and executed per regulatory and business requirements
• Assists in the development of regulatory strategies and filings for product approvals
• Provides regulatory support to cross-functional project teams in conjunction with direct manager
• Assists and/or prepares and submits Technical Files
• Assists and/or prepares and submits FDA submissions (e.g., PMAs, 510(k)s, progress reports, device listings)
• Reviews and approves change requests and Change Orders
• Assures that all submission documentation, record keeping, and reporting meet inspection standards as established by regulatory agencies worldwide
• Makes decisions involving worldwide submissions and provide advice and counsel to other team members with the assistance of direct manager
• Participates in cross-functional team meetings

QUALIFICATIONS:

• Minimum of 8 years of medical device regulatory affairs experience in a similar or equivalent role, preferably in neuromodulation
• Bachelor’s degree in engineering, science, or related disciplines; Master’s degree preferred
• Ability to develop and maintain excellent working relationships with regulatory agencies/bodies
• Knowledge of U.S. medical device regulations

At Nalu, base pay is just one part of the total compensation package. Base salary offered may vary depending on many factors including but not limited: work location, skill set, prior relevant work experience and training, education, licenses/certifications; and organizational needs.

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