Description
A Leading medical device company in Liverpool would like to bring on a Regulatory Affairs Manager to help bring medical devices to market and ensure ongoing compliance while mentoring less experienced colleagues in the development of their regulatory skills. This is a great, stable, innovative company that offers excellent salary, benefits and relocation, if needed.Responsibilities:
* Participate in New Product Development Teams throughout all phases to ensure US, EU, and other international regulatory requirements are incorporated as part of the development process.
* Evaluate medical device regulations and develop strategies for bringing products to market.
* Author FDA submissions, EU design dossiers, and other regulatory documents to obtain approval to bring new or modified products to market.
* Partner with global regulatory affiliates and leverage Reconstructive product expertise to provide submission documentation for expedited international market access and sustaining support.
* Assess global impact of changes to launched products and support notifications/submissions as required.
* Review labeling and marketing literature for compliance with regulatory requirements.
Needed:
* BA/BS in Science, Regulatory or Engineering. Advanced degree preferred; RAC certification preferred.
* 5-7+yrs. experience within medical device industry.
* Technical leadership in providing guidance, training, and mentoring to less experienced colleagues and cross-functional team members.
* Extensive knowledge of FDA Quality System Regulations (21 CFR), EU Medical Device Directives (MDD), applicable guidance documents, and additional international regulations.
* Significant 510(k), IDE, PMA, or CE Technical File/Design Dossier preparation, review, and submission experience.
* Significant experience interacting directly with FDA and Notified Body reviewers/inspectors
If this looks like an opportunity for you, please get in touch as well as sending your upto date CV as we are currently experiencing a high volume of applications for this role.
PLEASE NOTE:
Candidates with EU Citizenship only / Medical Device Regulatory Affairs experience required.
Marvin Trenchfied