Manager Regulatory Affairs, Biosurgery

Manager Regulatory Affairs, Biosurgery

The Manager Regulatory Affairs, Biosurgery will act as the primary and secondary regulatory support for several products.  The successful candidate will be responsible for defining regulatory strategies, regulatory plans and submissions in support of new and existing marketing authorizations.  Other responsibilities include developing and executing regulatory strategies, regulatory plans and submissions for projects including new products and maintenance of licenses/authorizations for existing marketing authorizations.  The candidate will act as the designated contact with the FDA and liaison with the project team for communication and negotiation in support of submission activity.  The incumbent will represent the Regulatory Affairs function on assigned cross-functional project teams.  Will monitor applicable regulatory requirements and assure compliance with the company and external standards.  The candidate will establish appropriate communication within Regulatory Affairs and other functions, primarily at the project level.  Other responsibilities will include performing gap analysis and proposing solutions as well as developing and documenting sound regulatory decisions and justifications.  The incumbent will ensure project teams and business objectives and deliverables are aligned with regulatory strategy.  This position may provide direct supervision of individuals and the review of promotional material or SOP’s for compliance with local and global regulations.  Requirements for this position include knowledge of Regulatory Affairs.  Experience with writing and managing submission activities for IDE, 510(k), and PMA submissions.  The candidate will also need scientific knowledge and the ability to manage complex projects and timelines in a matrix team environment.  Strong oral, written and presentation skills is needed, as well as solid interpersonal and negotiation skills.  The incumbent must have the ability to independently identify compliance risks and escalate them when necessary.  The ability to lead and coach others is also needed.  Requirements include a bachelor’s degree in related scientific discipline with a minimum of 5 years regulatory experience, including managing people and/or projects.  An MS or PhD is preferred.  Experience with IDE and Class III PMA submissions required.

Please refer to job code SD6544 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Grayslake, IL
County:	Lake County
ZIP Code:	60030
Pay Rate:	Open
Job Terms:	full time
Company:	The Cambridge Group Ltd.
Phone:	E-mail or fax only
Fax:	203-226-3856