The position, located at C. R. Bard Electrophysiology headquarters in Lowell, Massachusetts, reports to the Corporate Vice President Regulatory and Clinical Affairs and the President of Bard Electrophysiology. Your primary duties are:

·Development of regulatory strategies for new and modified devices including the preparation and timely submission to regulatory agencies leading to successful approvals.

·The development of divisional regulatory and clinical affairs policies, goals and executive reports.

·Determine effective regulatory procedures and project plans to ensure FDA regulations and Bard Electrophysiology goals are met.

·Works with cross-functional teams to collect, document, analyze and report information for inclusion in regulatory submissions.

·Provide divisional review and approval of product labeling, promotional claims and advertising to ensure compliance with Bard corporate policy, US and international laws and regulations.

·Lead a world-class clinical development department resulting in the timely collection of clinical data and information to support all submissions.

Candidate Requirements:

·We seek a seasoned regulatory and clinical development professional with a minimum of 10 years productive medical device submissions experience and a track record of successful 510(K), IDE and PMA submissions.

·We seek a professional with a degree in life sciences. Advanced academic training (MS, PhD, MBA) is highly desirable.

·For the best fit, you must be a strong leader, solid team player and excellent communicator capable of working collaboratively with colleagues in all functions and have developed and provided effective leadership for a successful, productive and well-respected RA/CA organization.

Compensation:

A compensation package will be designed to attract outstanding talent and will include a base salary, performance bonus and appropriate stock incentives