Lead Regulatory Affairs Specialist
Campbell, CA
Full Time
Regulatory Affairs
Experienced
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.
- 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 include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and 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.
The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.
Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.
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