Noah Medical
Staff Regulatory Specialist
Noah Medical, San Carlos, California, United States, 94071
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.
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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.
#J-18808-Ljbffr