Sr Regulatory Affairs Specialist
Campbell, CA
Full Time
Regulatory Affairs
Mid Level
Title: Sr 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 - As a senior professional in the field, this position will partner with functional group leaders to effectively meet regulatory requirements by delivering accurate, timely, and high quality regulatory documents, and projects in accordance with company objectives, policies and procedures. This role provides regulatory guidance on ongoing cross-functional projects to ensure compliance with FDA, U.S., and international regulatory requirements.
What You’ll Bring – minimum requirements for this role:
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: $120,000 – 130,000 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.
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 - As a senior professional in the field, this position will partner with functional group leaders to effectively meet regulatory requirements by delivering accurate, timely, and high quality regulatory documents, and projects in accordance with company objectives, policies and procedures. This role provides regulatory guidance on ongoing cross-functional projects to ensure compliance with FDA, U.S., and international regulatory requirements.
- Participate in development of and execute on regulatory strategy and priorities in alignment with company’s objectives and regulatory requirements.
- Collaborate and participate in cross-functional project teams to ensure regulatory guidelines are considered when setting deliverables, creating timelines and allocating resources.
- Review and approve Documents Change Order, CAPAs, NCRs, etc.
- Compile, prepare, review and submit high-quality regulatory submissions and filings such as Letter-To-File, 510(k), IDE, PMA, Design Dossier, Notified Body submissions and subsequent revisions/supplements and amendments, including all associated deliverables and timelines.
- In consultation with responsible Regulatory Affairs Management, interact and negotiate directly with regulatory authorities during the product development and review process to facilitate submission approvals.
- Prepare various presentations to regulatory agency reviewers and/or inspectors as needed.
- Communicate effectively with internal stakeholders and regulatory authorities as required.
- Ensure compliance with FDA and OUS regulations/guidelines as well as company SOPs/protocols.
- Maintain regulatory files and tracking databases as required.
- Prepare and maintain annual licenses, US and international registrations/listings for assigned geographies in a timely manner.
- Partner with Clinical Affairs to provide input and prepare critical data for physicians and proposals.
What You’ll Bring – minimum requirements for this role:
- Bachelor’s degree in related field and a minimum of 5 years of experience in related roles at healthcare, pharma, or medical device industries; or an equivalent combination of education/training and experience.
- An advanced degree or regulatory affairs experience in the medical device industry strongly preferred.
- Experience in the vascular or neurovascular space preferable.
- Proven ability preparing US and/or OUS regulatory submissions and assessing change order assessments.
- Excellent written and oral communication skills with strong technical writing capabilities are a must.
- Demonstrated ability to meet deliverables through successful project/documentation management, and strong 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 work quality and the ability to multitask and adapt to changing 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: $120,000 – 130,000 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.
Apply for this position
Required*