Staff Regulatory Specialist at Noah Medical
San Carlos, CA 94070
About the Job
Who We AreNoah 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 teamsAssess the impact of the product/process changes and determine regulatory pathwaySupport development teams on regulatory issues, including review of documentationWork directly with regulatory agencies on regulatory issues and submissionsEnsure compliance with FDA and OUS regulations and guidelines as well as relevant company SOPs and protocolsCoordinate international product registrations and licensing documentationAbout 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 companyMinimum 5 years of experience in submissions and technical documentation for medical devicesExperience with new product development projects for complex products with software, hardware and cybersecurity requirementsAbility to create and submit Q-subs, 510(k), and IDE submissions with minimum supervisionAbility to prioritize multiple projects independentlyStrong understanding of design controls with experience in verification and validation methods and documentationStrong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions and communication with regulatory bodiesExperience with global regulatory processes and submissions is a plus.Ability to review and provide critical feedback on design documentationGood interpersonal skills and project management skillsWorkplace Type: Hybrid Benefits & Perks (For Full Time Employees):Competitive SalaryComprehensive health insurance including Medical, Dental and Vision + HSA and FSA optionsEquity & Bonus ProgramLife Insurance (company paid & supplemental) and Disability insuranceMental health support through medical insurance programsLegal and Pet Insurance12+ paid holidays, 15-20 days of PTO + use-what-you-need sick daysPaid parental leaveIn-office snacks and beverages In-office lunch stipendLearning & Development Opportunities: On-demand online training and book reimbursementTeam building and company organized social and celebration events#LI-Hybrid Pay TransparencyThe 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.California Pay Range$168,800—$211,000 USDNoah 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.
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 teamsAssess the impact of the product/process changes and determine regulatory pathwaySupport development teams on regulatory issues, including review of documentationWork directly with regulatory agencies on regulatory issues and submissionsEnsure compliance with FDA and OUS regulations and guidelines as well as relevant company SOPs and protocolsCoordinate international product registrations and licensing documentationAbout 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 companyMinimum 5 years of experience in submissions and technical documentation for medical devicesExperience with new product development projects for complex products with software, hardware and cybersecurity requirementsAbility to create and submit Q-subs, 510(k), and IDE submissions with minimum supervisionAbility to prioritize multiple projects independentlyStrong understanding of design controls with experience in verification and validation methods and documentationStrong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions and communication with regulatory bodiesExperience with global regulatory processes and submissions is a plus.Ability to review and provide critical feedback on design documentationGood interpersonal skills and project management skillsWorkplace Type: Hybrid Benefits & Perks (For Full Time Employees):Competitive SalaryComprehensive health insurance including Medical, Dental and Vision + HSA and FSA optionsEquity & Bonus ProgramLife Insurance (company paid & supplemental) and Disability insuranceMental health support through medical insurance programsLegal and Pet Insurance12+ paid holidays, 15-20 days of PTO + use-what-you-need sick daysPaid parental leaveIn-office snacks and beverages In-office lunch stipendLearning & Development Opportunities: On-demand online training and book reimbursementTeam building and company organized social and celebration events#LI-Hybrid Pay TransparencyThe 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.California Pay Range$168,800—$211,000 USDNoah 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.
