Director Quality and Regulatory Affairs

Company: JJ Sonik
Location: Irvine
Posted on: March 28, 2020

Job Description:

At JJ Sonik, we bring individuals and companies together with a specialization in relocation.--Top three reasons to consider relocation:---- You can always come back home. Today, companies don't expect you to retire from the Organization. Commit to a time frame, 3-5 years often represents a return of investment for both parties. Evaluate at that time.---- Positions that require relocation commonly pay higher than positions that can hire from a local candidate pool. You can take that compensation level with you for your entire career. That can have a lifetime impact of hundreds of thousands of dollars.---- It isn't really that dramatic or complicated. We are masters at making the transition seamless.--So, if you or someone you know has the following experience and is open to the possibility of an opportunity away from Irvine, please reply in confidence.----We'll tell you all about the position including its location. Give us an opportunity to tell you what we like about it.--Qualifications and Responsibilities for the Director Quality and Regulatory Affairs--The Director Quality and Regulatory Affairs will provide corporate regulatory and quality leadership across a global organization.--He/she will maintain corporate policies and practices to support changes in global regulatory and quality compliance.--He/she will build and strengthen relationships with regulatory and quality authorities and provide timely expert input to deliver innovative regulatory and quality strategies for product development, manufacturing, and registration.--The Director will influence and lead change to implement new programs, policies, and processes for the recommendation of regulatory and quality strategies.--He/she will lead a global regulatory affairs and quality assurance department. This role will be the lead regulatory and quality authority at the Medical Device Company.--Bachelor's degree in a scientific discipline, advanced degree preferredMinimum 8 years' regulatory and quality experienceMinimum 6 years' experience in a medical device companyProficiency in Global Regulatory and Quality standardsExperience working with the FDA and International regulatory authorities from pre-approval and/or post-marketing, with a proven track record of submissions and approvals?Proven ability to provide strategic guidance to a global regulatory and quality department

Keywords: JJ Sonik, Irvine , Director Quality and Regulatory Affairs, Executive , Irvine, California