Regulatory Affairs Specialist Job in Lowell 01850, Massachusetts US

Sr. RA Specialist WANTED.  We are searching for a Senior Regulatory Affairs Specialist or Associate to join a premier company in the Lowell, MA area.  Jobs of this nature typically range in salary up to $85K and offer full benefits package.  If you are interested and qualified, simply email your resume to:

You must have the following experience in order to be considered for this position:

• Bachelor’s Degree.  Advanced degree preferred.
• Minimum 3 years of experience in Medical Device regulatory affairs

• FDA submissions experience including filing 510k, PMA, IDE and CE-mark applications.
• Experience with regulatory clearance process for newly developed CL II III medical devices.
• Experience with manufacturing from a materials, design, and process standpoint.
• Strongly Preferred:  Experience with global medical device regulations including Canada, EU, and Japan.

• Strongly Preferred:  Regulatory Affairs Certification for US, Europe and Canada


The Senior Regulatory Affairs Specialist maintains regulatory compliance by ensuring timely and accurate submissions to the FDA, EU, and other international regulatory agencies, and by working with various departments and project teams to provide regulatory subject matter expertise.  The Sr. RA Specialist is charged with ensuring quick approval for new devices and for providing support of current products.  This position interacts closely with regulatory agencies and routinely submits 510(k), PMA, IDE, and CE-mark applications for approval.  Project Leader Certification and 6-Sigma skill is helpful in this role but not required. 

PRIMARY DUTIES/RESPONSIBILITIES:

•      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.

•      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.

 

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This is an urgent search and you are encouraged to apply quickly 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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