REGULATORY AFFAIRS MANAGER Job in Lowell 01852, Massachusetts US

RA MANAGER WANTED!  We are searching for a Regulatory Affairs Manager for a premier Medical Device company in the Lowell, MA area.  This RA Manager opportunity calls for extensive medical device regulatory experience including multiple FDA submissions of  510(k), IDE, PMA, etc.  This growing company anticipates multiple submissions over the course of the next year.

Positions of this nature typically have a salary range of $105,000 to $130,000 depending on the level of experience.  This is a full time position and offers a full benefits package. 

This position has several mandatory requirements.  If you meet these mandatory requirements and are interested, please apply quickly as interviews are being scheduled.

Mandatory Requirements:

·         BS Degree required, preferably in a Scientific or Engineering discipline.  Advanced degree preferred.

·         Minimum 8-years medical device regulatory affairs experience, especially international submissions.

·         Demonstrated knowledge of FDA regulations and International Conference of Harmonization (ICH) and Good Manufacturing Practices (cGMP).

·         Demonstrated knowledge of current US and international regulations and guidelines, the medical device development process, and for adverse event reporting.

·         Experience with regulatory filings and submissions (510(K),  IDE, PMA) with favorable clearance and approval times. 

·         Strong leadership skills and the ability to advance into positions of increased scope and responsibility within one to two years.

·         Ability to commute within a 10-mile radius of Lowell, MA.

 

DUTIES RESPONSIBILITIES:

•             Sets the strategic regulatory strategy for the company and effectively manages staff and resources to accomplish regulatory and business objectives.

•             Obtains and generates information to be submitted to regulatory authorities and prepares required regulatory submissions.

•             Acts as liaison with appropriate local, national and international regulatory authorities.

•             Provides regulatory guidance to sales, marketing, and manufacturing  groups, as appropriate, for both onsite and remote-offsite activities.

•             Oversees the maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations.

•             Review changes in manufacturing facilities, manufacturing procedures, and analytical methods.

•             Represent regulatory on project planning and review meetings; participates in final document review and corrections.

•             Identifies and ensures the establishment and monitoring schedules for submission documentation, review of documentation, protocols and reports received; prepares additional written materials as needed.

•             Coordinates and prepares 510(k) Pre-market Notifications, IDEs, PMAs, Technical Files and Design Dossiers.

•             Prepares responses to FDA letters, supplements, and amendments; participates in ISO and customer audits and FDA inspections and presentations.

•             Writes departmental SOPs as needed.

•             Provides input for preparation of departmental budget; ensures that the department operates within capital and expense budget guidelines.

•             Keeps apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company.

•             Read related regulatory publications and documents; presents information about current regulatory actions.

•             Performs all other related duties as directed by management.

 

THIS IS AN URGENT SEARCH AND YOU ARE ENCOURAGED TO APPLY IMMEDIATELY IF INTERESTED AND QUALIFIED.

Hiring Authorities, Inc., is a global recruiting firm specializing in the Medical Device, Pharmaceutical, Biotechnology, and related industries.  We place multiple candidates each month at World Class companies.  More information on us may be seen on our website or in MEDICAL DEVICE magazine.  Follow Hiring Authorities, Inc on Linkedin.com.

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