About Us

Neuronetics, Inc. is a leading mental health company dedicated to transforming lives through innovative treatments. Now joined with Greenbrook Mental Wellness Centers, we offer FDA-cleared NeuroStar® TMS and Spravato® therapies for major depressive disorder and treatment-resistant depression across 95+ clinics nationwide. Together, we’re expanding access to life-changing care—combining cutting-edge technology with clinical expertise to make a real impact in the mental health space.

Position Overview:

The Director, Regulatory & Medical Affairs is responsible for the operational oversight of the Regulatory and Medical Affairs teams.  The position establishes the organization’s Regulatory strategy and roadmap, leading the development and maintenance of all required processes and procedures, and ensuring all work products of the business are compliant with applicable regulatory requirements. The Director collaborates with new product development and clinical programs in developing 510(k) submissions and global registration plans.  The Director works with cross-functional teams to develop strategies to secure regulatory clearance for new indications and new products in US and OUS markets.

The position also oversees Postmarket Surveillance activities of the Medical Affairs team including but not limited to handling medical complaints, Safety Committee meetings, and adverse event determination and filing. 

Essential Duties/Responsibilities:

·       Manage Regulatory and Medical Affairs SOPs to ensure full compliance with global regulatory requirements. 

·       Maintain current knowledge of changes to relevant global regulatory standards and manage implementation of those changes into company business processes.

·       Work proactively cross-functionally to ensure new product development, new clinical indications, and post market activities comply with internal processes and global regulatory standards.  

·       Develop the strategy and manage the creation, review, and edit of documentation for US and OUS regulatory submissions. 

·       Manage and maintain ongoing submissions such as annual reports, medical device facility registrations and device listings.

·       Support efforts in review and approval of product labeling, technical publications, and promotional materials, assuring regulatory requirements are met, safety warnings and precautions are adequate, and all product claims are properly supported.

·       Oversee medical complaint handling, Safety Committee meetings, adverse event review and reporting globally.

·       Perform duties as the main Regulatory Contact for FDA, Person Responsible for Regulatory Compliance, or “PRRC" (per EU MDR), and other Regulatory Bodies including supporting audits, as applicable.

·       Oversee and serve as alternative GUDID Coordinator and Label Data Entry User for GUDID/other UDI database data entry, as required.

·       Provide input to ensure the training programs for company staff covers the relevant regulatory requirements.

·       Other Duties as needed or required.

Knowledge, Skill, and Abilities:

•         Strong knowledge of 21 CFR 820, ISO 13485, ISO 14971, ISO 10993, EU MDR, MDSAP and US/global UDI requirements, including UDI database entry requirements.

·       Well-versed in postmarket surveillance monitoring and reporting activities, including those for FDA and EU MDR. 

·       Strong organizational skills, self-directed, attentive to details, and able to multitask.

·       Strong problem-solving skills and ability to deal with changing priorities.

·       Success with developing strategies for clearance of new and expanded indications for use

·       Excellent written, verbal, and presentation skills.

Education and Experience:  

·       BS/BA degree, or equivalent, in life sciences related field.

·       RAC certification.

·       15+ years Regulatory Affairs in medical device field with management responsibilities.

·       Strong understanding and experience with US and global regulatory requirements for class II medical devices including but not limited to 21 CFR 820, ISO 13485, ISO 14971, ISO 10991, EU MDR, and MDSAP.

·       Direct experience with FDA and notified body audits and negotiations.

Preferred Skills:

·       Advanced Degree preferred.

Physical Requirements:

·       Must be able to remain in a stationary position 50%-75%

·       Walking/Bending/Stooping 50%-75% to access file cabinets, office equipment, etc.

·       Light to moderate lifting (up to 50lbs) 

·       Some travel maybe required by air, rail or auto within the United States

 *Applicants must be authorized to work for any employer in the US. We are unable to sponsor or assume responsibility for employment visa/work authorization at this time.

Neuronetics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Neuronetics makes hiring decisions based solely on qualifications, merit, business needs at the time.