Lead Regulatory Affairs Specialist

Imperative Care; Campbell (CA); On-site; USD 151,000 - 178,000; Full time

Benefits offered by this job

a stake in our collective success with

stock options

competitive salaries

a 401k plan

health benefits

generous PTO

a parental leave program

Job summary

Imperative Care, based in Campbell, California, seeks a Lead Regulatory Affairs Specialist for on-site, full-time employment. You will lead regulatory strategies for product changes and new development, coordinating with cross-functional teams to ensure FDA and international compliance, and managing filings such as 510(k) and Notified Body submissions.

The role requires a strong background in US/OUS submissions, regulatory operations, and excellent communication.

Qualifications

• Bachelor’s degree in related field with a minimum of 8 years of regulatory experience in healthcare, pharma, or medical devices.
• Advanced degree or strong regulatory affairs experience highly preferred.
• RAC certification is a plus.
• Strong written and verbal communication skills with ability to work independently and in a team.
• Experience with US and international regulatory submissions and change orders.

Responsibilities

• Execute regulatory strategies for product changes and development in line with company objectives.
• Advise cross-functional teams on regulatory requirements for bench, animal, and human clinical plans; review and approve Design Control deliverables.
• Prepare regulatory documents and filings (e.g., 510(k), Notified Body submissions, and international submissions) and manage timelines.
• Serve as primary contact to regulatory reviewers and coordinate timely responses to deficiency questions.
• Lead multiple regulatory projects, ensuring objectives, resources, and deadlines are met.
• Review and approve Document Change Orders, CAPAs, NCRs, and related documents.
• Support regulatory operations (establish registrations, device listings, UDI, licenses) and maintenance.
• Develop regulatory procedures and align with US and international compliance.
• Support Operations and yield improvement projects.
• Provide regulatory documents for management review.

Education

Bachelor’s degree in related field

Advanced degree

Job description

Title:Lead Regulatory Affairs Specialist

This position is based in our Campbell, California offices. This position is on-site, full-time.

Why Imperative Care?

Do you want to make a real impact on patients? As part of our team at Imperative Care, you can help elevate care for patients suffering from stroke and other devastating vascular diseases. Every day, the technologies that we develop at Imperative Care directly impact people at the most vulnerable moments of their lives. Our focus is on the needs of the patient, and they come first in everything we do.

What You’ll Do

An individual in this role uses advanced expertise to offer pre-commercial and commercial regulatory advice on projects related to product changes, new product development, and regulatory operations to comply with FDA and international medical device regulatory requirements, as applicable. An individual in this role will partner with cross functional team members to deliver accurate, timely, and effective regulatory assessments, strategies, documents, and other project deliverables in line with company objectives, policies and procedures.

• Execute regulatory strategies for product changes and/or new product development in alignment with company objectives.
• Participate in cross-functional project teams to advise on regulatory affairs related to bench, animal, and human clinical test plans, reviewing and approving Design Control deliverables, providing information and offering recommendations that reduce regulatory risks, keep benefits, and stay within specified timelines as project deliverables are understood and incorporated to the plan.
• Prepare regulatory documents and filings such as but not limited to Letters-To-File, Pre-Submissions, Investigational Device Exemptions, 510(k)s, Technical Documentation Files, Notified Body submissions, other international submission support as applicable, and subsequent revisions/supplements and amendments by managing deliverables and timelines.
• Serve as the main point of contact to regulatory agency reviewers on submissions, coordinate with internal team members to respond to deficiency questions in a timely manner and engage with regulatory agency reviewers for favorable outcomes.
• Leads multiple regulatory projects at one time and ensures objectives, resources and deadlines are met.
• Review and approve Document Change Order requests, CAPAs, NCRs, and other documents as applicable.
• Participate in regulatory operations, e.g. establishment registration, device listings, UDI, medical device license and certificate maintenance, supporting customs requests, etc.
• Participate in the development of procedures for the regulatory function and provide input to procedures owned by other functions as needed with a focus on both US and international compliance.
• Support the Operations teams and yield improvement projects.
• Provide regulatory documents (i.e., Letters to File, Submissions to regulatory Agencies, etc.) for management review.

What You’ll Bring

• Bachelor’s degree in related field and a minimum of 8 years of experience in related roles at healthcare, pharma, or medical device industries; or an equivalent combination of education/training and experience.
• Primary authorship of US and/or OUS regulatory submissions and change order regulatory assessments.
• Advanced degree or strong regulatory affairs experience in medical device industry strongly preferred.
• High level of expertise in Vascular space is preferable.
• EU MDR, MDSAP experience a plus.
• Strong expertise preparing US and/or OUS regulatory submissions and change order assessments.
• Excellent written and oral communication skills; technical writing capabilities are a must.
• High level of expertise in attaining deliverables through successful project/documentation management, and organizational skills.
• Ability to exercise independent judgment and decision making for complex situations/programs.
• RAC certification a plus.
• Independent yet able to work in a team; detailed approach to work assignments; high standards for quality of work and able to multitask and adapt to frequent shifts in priorities with a sense of urgency.

Employee Benefits

• a stake in our collective success with stock options
• competitive salaries
• a 401k plan
• health benefits
• generous PTO
• a parental leave program

Join Us!

Imperative Care

Salary Range: $151,000 – 178,000 annually

Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, health benefits, generous PTO, a parental leave program and emotional health resources.