This position, located at Bard Electrophysiology Division in Lowell, MA and reports to the Vice President of Regulatory and Clinical Affairs. Responsibilities include:

· Prepare and submit PMA, IDE, 510(k) and international product registrations and licensing applications (original submissions and subsequent product enhancements).

· Interpret new or existing regulatory requirements as they relate to company products and procedures.

· Must be in compliance with Good Clinical Practices (GCP), FDA regulations, ISO 9001/2 and BEP's standard operating procedures.

· Schedule, write and/or review and approve all regulatory submissions.

· Implement and comply with the quality system manual and supporting BEP procedures.

· Research changes in regulations effecting medical devices and communicate changes to management team.

· Communicate and cooperate with R&D engineers as well as with other company personnel to achieve BEP's goals.

· Continually look for ways to improve processes, procedures and products, evaluating and participating in improvements as appropriate.

· Prepare clinical reports and regulatory submissions. Coordinate preparation and presentation of clinical data for reports; write reports for regulatory submissions.

· Participate in and provide input to clinical and R&D project teams to assure that FDA and international requirements are incorporated as part of the product development process.

· Review and advise on labeling, product claims, marketing brochures and other publications to ensure compliance with regulations.

· Compile and present trending analysis of adverse events.

· Interface directly with FDA reviewers and international regulatory officials as required.

Candidate Requirements:

· Five to seven years experience in preparation and submission of FDA submissions PMA, IDE, 510(k)) for Class I, II and III devices.

· Bachelor's degree in a technical area or equivalent industry experience.

· Strong working knowledge of regulatory requirements for European community, Japan, Canada and other countries as well as a working knowledge of QSR, ISO and EN standards.

· Excellent communication skills - both written and oral.

· Ability to review and evaluate scientific and technical data.

· Ability to work effectively on project teams.

· For the best fit, you should be a hands-on, results-oriented professional who is a strong team player with excellent written and oral communications, and capable of working independently.

Compensation:

A compensation package will be designed to attract outstanding talent and will include a base salary, performance bonus, a long-term incentive plan and an attractive benefits package.