Director, Regulatory Affairs

Applied Medical, a progressive medical device developer and manufacturer, invites exceptional individuals to pursue careers in our innovative organization.  If you would like to be a part of one of the fastest growing and most innovative companies in the medical device industry, then Applied Medical is the place for you.  Applied?s team members enjoy an environment that allows opportunity for growth and choice in individual career paths as team members develop their skills, training and business knowledge.  Our common goal of improving healthcare through meeting the needs of clinicians and patients is achieved through the dynamics of our team and its universal dedication to improved patient outcome. 

 

Job Description:  Regulatory Director

 

The Director of Regulatory, will incorporate the Quality Policy into all aspects of the job.  This includes working as a team member, striving to meet and exceed external and internal customer expectations and committing to continuous qualify improvement.

 

The Director of Regulatory under general supervision, is responsible for: a) Preparing FDA Submissions which may include device listing, 510 (k)s, PLAs, or IDEs, b) conducting all activities associated with the internal audit program, c) Serving as regulatory representative on selected projects teams, d) Establishing and implementing validation programs. 

 

Job requirements:

 

This position requires the following skills and attributes:

 

FDA Regulatory Submissions:Prepares and updates device listings, facility registration, and any other reports or certifications required by the Food and Drug AdministrationPrepares 510(k), IDE, and PMA submissionsCommunicates with FDA regarding 510(k) status and requirements

 



Internal Audit Program:Schedules, plans and notifies appropriate individuals of upcoming auditsServes as a primary auditor during internal Quality System AuditsPerforms unplanned ?walk-through? auditsIssues corrective action Requests (CAR?s ) and follow-up corrective action Trains audit team membersMonitors implications of CAR?s to detect trends and takes action to achieve compliance

 

Project Team Representative:Attends team meetings and provides guidance relative to regulatory issuesCommunicates with Regulatory Affairs departmentDirects team activity regarding regulatory requirements and schedule

 

Validation Activities:Establishing, implementing and maintaining software development and validation processesDefining software and process validation requirementsCoordinating software, process verification and validation activitiesProviding support to project teams in defining and reviewing product and software requirementsProviding training to personnel engaging in validation activitiesImplementing, supporting, and sustaining elements of the Company?s regulatory and <li>quality system through procedure generation, training, auditing, and technical support Collaborating with engineering and manufacturing for validation studies and capability studies

 

Required:

Medical Device background5 - 7 years experienceBS or industry experience equivalence

 Company Benefits:

Applied Medical offers an excellent and competitive compensation and benefits package.  Applied Medical is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, or national origin.

 Job Application:If you are interested in joining Applied Medical and meet the job requirements above, please forward your resume to the email address or fax number below.  For more information on Applied Medical, please visit our website at www.appliedmedical.com

 

Contact Information: DirRegulatory@appliedmed.com

949-713-8205 fax

 Keywords:

CRO, Technical file, ISO, FDA