Director of Regulatory Affairs

Connexion Systems & Engineering, a Boston based IT and Engineering Solutions Company immediately seeks individuals with the following skills:

 

Job# 5602

 

Director of Regulatory Affairs

 

Responsibilities: The Manager/Director of Regulatory Affairs is responsible for developing and executing the global Regulatory strategies and activities of the company.

? Support multidisciplinary project teams by providing Regulatory input and strategy.

? Manage regulatory aspects of complaint handling activities as a member of the Incident Review Board.

? Determine strategy and requirements for 510k?s.

? Coordinate, prepare and manage IDE, 510(k), and PMA, submissions, supplements and annual reports as well as International registration submissions

? Lead in all communication and negotiations with FDA relating to requirements for device approvals including clinical protocols.

? Review, advise and approve labeling, including sales and marketing materials, protocols, publications and control changes for regulatory compliance.

? Support all internal and external engineering efforts in the development and design of new products.

? Responsible for training and maintaining FDA compliance requirements are met and written procedures are followed.

? Manage the development, implementation, update and maintenance of regulatory systems and activities.

? Orchestrate and implement the internal audit program.

? Actively participate in Regulatory Affairs meetings to remain up to date on potential changes in FDA policy or surveillance activities particularly as they relate to the Company?s business.

 

Skills, Education and Experience:

? Bachelor of Science or equivalent with advanced degree preferred.

? Minimum of 5 years experience in Regulatory field for medical device company.

? Experienced leader with exceptional interpersonal and communication skills.

? Must be organized with attention to detail.

? Prior experience and direct interaction with FDA review panels and processes.

? Solid understanding of international regulatory standards; FDA, CE and MHW.

? Ability to multitask and work in entrepreneurial environment.

? Solid computer and written communication skills.

 

Duration:  Permanent 

 

Rate: Open

Location:  Lexington, MA 

 

Contact Info:

Ken DiMaggio

ConneXion Systems & Engineering

490 Boston Post Road

Sudbury, MA 01776

978-579-0030

ken.dimaggio@csetalent.com