Who We Are
Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery.
About The Team:
The Staff Regulatory Specialist’s primary responsibility is to prepare regulatory submissions, filings, dossiers, Letters to File, and to provide recommendations to the research and development teams during the product development to ensure compliance with regulatory requirements. Also serves as a key member of Postmarket and Compliance function. This is an individual contributor role with a potential for becoming a functional manager.
A Day In The Life Of Our Staff Regulatory Specialist :
- Prepare and submit regulatory filings including Q-Subs, IDEs, 510(k)s, de Novos and ROW submissions.
- Identify and interpret requirements from applicable standards and guidance documents to development teams
- Assess the impact of the product/process changes and determine regulatory pathway
- Support development teams on regulatory issues, including review of documentation
- Work directly with regulatory agencies on regulatory issues and submissions
- Ensure compliance with FDA and OUS regulations and guidelines as well as relevant company SOPs and protocols
- Coordinate international product registrations and licensing documentation
About You:
- Education: Minimum B.S. or higher in Engineering or in a Science field or equivalent related experience
- Minimum 6 years experience working in regulatory function of a medical device company
- Minimum 5 years of experience in submissions and technical documentation for medical devices
- Experience with new product development projects for complex products with software, hardware and cybersecurity requirements
- Ability to create and submit Q-subs, 510(k), and IDE submissions with minimum supervision
- Ability to prioritize multiple projects independently
- Strong understanding of design controls with experience in verification and validation methods and documentation
- Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions and communication with regulatory bodies
- Experience with global regulatory processes and submissions is a plus.
- Ability to review and provide critical feedback on design documentation
- Good interpersonal skills and project management skills
Workplace Type: Hybrid
Benefits & Perks (For Full Time Employees):
- Competitive Salary
- Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
- Equity & Bonus Program
- Life Insurance (company paid & supplemental) and Disability insurance
- Mental health support through medical insurance programs
- Legal and Pet Insurance
- 12+ paid holidays, 15-20 days of PTO + use-what-you-need sick days
- Paid parental leave
- In-office snacks and beverages
- In-office lunch stipend
- Learning & Development Opportunities: On-demand online training and book reimbursement
- Team building and company organized social and celebration events
#LI-Hybrid
Pay Transparency
The Pay Range for this position is listed. Consistent with applicable laws, an employee's pay within this range is based on a number of factors which include but are not limited to relevant education, skills, job-related knowledge, qualifications, work experience, credentials, and/or geographic location of the posted role. Noah Medical reserves the right to modify this range as needed based on candidate experience level and/or specialized skills. Please note that the aforementioned range is only one component of the position's total compensation package.
Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable.
Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws.
Please visit our Careers Page to view our latest openings.
