Nalu Medical, Inc
Sr. Regulatory Affairs Associate
Nalu Medical, Inc, Carlsbad, California, United States, 92002
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Sr. Regulatory Affairs Associate
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Nalu Medical, Inc. Join to apply for the
Sr. Regulatory Affairs Associate
role at
Nalu Medical, Inc. This range is provided by Nalu Medical, Inc.. Your actual pay will be based on your skills and experience talk with your recruiter to learn more. Base pay range
$110,000.00/yr - $140,000.00/yr 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 Bachelors degree in engineering, science, or related disciplines; Masters degree preferred Ability to develop and maintain excellent working relationships with regulatory agencies/bodies Knowledge of U.S. medical device regulations Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Full-time Job function
Job function
Legal Industries
Medical Equipment Manufacturing Referrals increase your chances of interviewing at Nalu Medical, Inc. by 2x Sign in to set job alerts for Senior Regulatory Affairs Associate roles.
Carlsbad, CA $114,100.00-$211,900.00 1 week ago Carlsbad, CA $114,100.00-$211,900.00 1 week ago Carlsbad, CA $115,000.00-$130,000.00 1 week ago Carlsbad, CA $100,000.00-$120,000.00 3 days ago Carlsbad, CA $100,000.00-$120,000.00 3 weeks ago Manager, Vendor Contracts & Regulatory Affairs
Manager, Regulatory Affairs - Hybrid - 134458
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Sr. Regulatory Affairs Associate
role at
Nalu Medical, Inc. Join to apply for the
Sr. Regulatory Affairs Associate
role at
Nalu Medical, Inc. This range is provided by Nalu Medical, Inc.. Your actual pay will be based on your skills and experience talk with your recruiter to learn more. Base pay range
$110,000.00/yr - $140,000.00/yr 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 Bachelors degree in engineering, science, or related disciplines; Masters degree preferred Ability to develop and maintain excellent working relationships with regulatory agencies/bodies Knowledge of U.S. medical device regulations Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Full-time Job function
Job function
Legal Industries
Medical Equipment Manufacturing Referrals increase your chances of interviewing at Nalu Medical, Inc. by 2x Sign in to set job alerts for Senior Regulatory Affairs Associate roles.
Carlsbad, CA $114,100.00-$211,900.00 1 week ago Carlsbad, CA $114,100.00-$211,900.00 1 week ago Carlsbad, CA $115,000.00-$130,000.00 1 week ago Carlsbad, CA $100,000.00-$120,000.00 3 days ago Carlsbad, CA $100,000.00-$120,000.00 3 weeks ago Manager, Vendor Contracts & Regulatory Affairs
Manager, Regulatory Affairs - Hybrid - 134458
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr