Job summary
Job post source
This job is directly from Nalu Medical, Inc.
Job overview
The Sr. Regulatory Affairs Associate at Nalu Medical, Inc. leads regulatory strategy and filings to ensure product approvals and compliance with medical device regulations, impacting product development and market access.
Responsibilities and impact
The role involves maintaining regulatory knowledge, providing expert guidance on regulations, coordinating submissions, supporting cross-functional teams, preparing regulatory filings like FDA submissions and Technical Files, reviewing change requests, and ensuring compliance with inspection standards.
Compensation and benefits
The position offers a salary range of $110,000 to $140,000 per year. No additional benefits or bonuses are specified in the description.
Experience and skills
Candidates must have at least 8 years of medical device regulatory affairs experience, preferably in neuromodulation, a bachelor's degree in engineering, science, or related fields, with a master's degree preferred, and strong knowledge of U.S. medical device regulations and regulatory agency relations.
Company overview
Nalu Medical, Inc. specializes in developing innovative neurostimulation devices for chronic pain management. They generate revenue through the sale of their advanced miniaturized implantable devices, which offer a less invasive and more effective alternative to traditional pain relief methods. Founded in 2014, Nalu Medical has made significant strides in the medical technology industry, securing multiple patents and FDA approvals. Their commitment to improving patient outcomes has positioned them as a leader in the field of neuromodulation therapy.
How to land this job
Position your resume to highlight extensive experience in medical device regulatory affairs, emphasizing familiarity with FDA regulations, PMAs, 510(k)s, and global submission standards relevant to Nalu Medical, Inc.'s neuromodulation products.
Focus on showcasing your ability to develop regulatory strategies, manage submissions, and collaborate cross-functionally, as these are key responsibilities in the job description.
Apply through multiple channels including Nalu Medical's corporate careers page, LinkedIn, and specialized medical device job boards to maximize application visibility.
Connect on LinkedIn with regulatory affairs professionals and team members at Nalu Medical, Inc. Use ice breakers like commenting on recent FDA approvals or expressing interest in their neuromodulation product innovations to start conversations.
Optimize your resume for ATS by incorporating keywords such as 'regulatory submissions,' 'FDA,' 'PMAs,' '510(k)s,' 'neuromodulation,' and 'cross-functional collaboration' to ensure your resume passes automated screenings.
Leverage Jennie Johnson's Power Apply feature to automate tailored applications, identify multiple application portals, and find LinkedIn contacts, allowing you to focus your energy on meaningful networking and interview preparation.
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