Regulatory Affairs Specialist

Regulatory Affairs Specialist

Job title: Regulatory Affairs Specialist

Location: Mansfield, MA Duration: 5+ months (possibility of extension) ROLES AND RESPONSIBILITIES:

· The skills required include a Regulatory Affairs contracted professional with experience working on product development teams, familiarity with FDA regulations for medical devices, submission experience of 510(k)s, generation of files necessary for outside U.S. notification and registration of medical devices, pre-clinical and/or clinical research, familiarity with ISO 14971, U.S. regulation 21 CFR 820, EC Directives 93/42/EEC as amended by Directive 2007/47/EC, EN ISO 13485, an understanding of basic safety requirements for medical devices, knowledge of current trends within U.S. and European medical device regulations, and intimate knowledge of regulations regarding reprocessing of medical devices in the U.S.

· Provide regulatory assessments of manufacturing, design, material, and labeling changes.

· The candidate will participate in Change Development Process (CDP) meetings and provide Regulatory feedback as appropriate.

· Deliverables to the CDP process will include written assessments that document regulatory impact as a result of proposed changes.

· Serve as RA team member on assigned maintenance of business projects.

· The major deliverables are generally regulatory assessments, US letter to file (RAD), global regulatory strategy plans (GRSP), collaboration with RA International team to determine impact, and collaboration with the project team to review DHF documentation including but not limited to test protocols and reports.

· Review and approve advertising and promotional materials.

· This activity includes close cooperation with the Marketing organization.

· Review and approval of product labeling