What are the responsibilities and job description for the Sr Manager Regulatory Affairs position at Imperative Care?
Title: Sr Manager Regulatory Affairs
This position is based in our Campbell, California offices. This position is on-site and 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 strong tactical decision maker, this role will oversee the day-to-day activities for a team of Regulatory Affairs Specialists. An individual in this role will partner with cross-functional teams and external consultants to efficiently deliver accurate, timely, and effective regulatory documents, deliverables, and other projects in line with company policies and procedures. This position will provide regulatory guidance with various ongoing cross-functional projects to remain in compliance with all FDA and other U.S. and international regulatory requirements.
- Develop and maintain relationships with Senior Management and other key stakeholders to support design and execution of the company’s regulatory strategy and priorities.
- Engage in problem-solving with cross-functional groups to influence company strategies and decisions as they relate to Regulatory activities.
- Make independent decisions for routine regulatory strategies and tasks; for more complex issues consult with regulatory senior management.
- Coach, mentor, and train a team of Regulatory Affairs Specialists in regulatory requirements, project team support, and creative approaches to new devices and device change assessments as described in the following areas.
- Prepare regulatory filings such as 510(k), IDE, PMA, Design Dossier, Notified Body submissions and subsequent revisions/supplements and amendments including associated deliverables, and timelines.
- Represent Regulatory discipline in Project Teams to ensure timelines and appropriate resource allocations are factored into deliverables.
- Participate in the development of global regulatory strategies for various projects.
- In consultation with Regulatory leadership, prepare cross-functional teams and senior management for regulatory agency discussions and negotiations; may lead the interactions in teleconferences and face-to-face meetings.
- Key contact for FDA and Notified Body submissions and onsite audit management.
- Based on Regulatory knowledge and experience, devise creative approaches to compliantly solve difficult challenges.
- Communicate information on device intended use and supporting data to help ensure company compliance of advertising and promotional materials.
- Establish operational objectives, policies, procedures and work plans to improve department and company-wide activities.
- Review and approve applicable design and manufacturing changes, Document Change Order requests, CAPAs, NCRs, etc.
- Ensure compliance with FDA and OUS regulations and guidelines as well as relevant company SOPs and protocols.
- Develop and maintain relationships with cross-functional stakeholders.
- Manage coordination of international product registrations and licensing documentation.
- Partner with Clinical Affairs to provide input to clinical data requirements for regulatory submissions and prepare critical data for physicians.
- Bachelor’s degree in a related field and a minimum of 8 years of experience in healthcare-related or medical device industries; or a combination of education/training and experience
- Prior people management experience strongly preferred.
- Experience with IDEs, PMAs and 510(k) filings, EU Medical Device Regulations, and other international submissions.
- An advanced degree is desirable; experience with intravascular technologies is a plus.
- Excellent written and oral communication skills; technical writing capabilities are a must.
- A proven decision maker, hands-on and action-oriented style must be evident.
- RAC certification a plus.
- Proven ability to manage a team of regulatory professionals and prioritize and execute on multiple projects independently.
Join Us! Imperative Care
Salary Range: $180,000 – 190,000 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.
Salary : $180,000 - $190,000
