Specialist, Prin Reg Affairs - 100315 - Marlborough, MA - 0300 Posted Date: August 22, 2013

Job Description

Prin Regulatory Affairs Specialist, Endoscopy
Key Responsibilities:
·          Prepares submissions to obtain and maintain global regulatory approvals for clinical research and commercial distribution of products.
·          Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
·          Acts as company representative, developing and maintaining positive relationships with regulatory agency reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.
·          Develops and implements regulatory strategies for new and modified products.
·          Provides regulatory guidance and direction as a core member on manufacturing and development teams, throughout the product development cycle, and identifies/coordinates cross functional deliverables for submissions.
·          Reviews and approves device labeling and advertising materials for compliance with global regulations; analyzes and recommends appropriate changes.
·          Reviews and approves product and manufacturing changes for compliance with applicable regulations.
·          Supports highly technical or major business segment product lines, special projects or strategic initiatives.

Experience Required

Qualifications:· Bachelor?s degree or equivalent work experience, preferably in a scientific or technical discipline· Professional certification(s) preferred· 8+ years Regulatory Affairs, Medical Device experience required. International experience a plus· Demonstrated success in management of regulatory submissions activities including 510k, PMA experience a plus· Thorough understanding of global regulations· Strong technical knowledge of medical products· Strong technical understanding of relevant procedures, practices, and associated medical terminology· Strong knowledge of clinical trial strategy and study design, and sponsor reporting requirements· Thorough knowledge of product development process and design control. · Excellent research and analytical skills· Ability to manage multiple projects· Excellent written and oral communication, technical writing and editing skills· Strong leadership, interpersonal and influencing skills· Proficiency with Microsoft OfficeWorking Conditions: General office environment with potential minimal travel (domestic and international) to BSC facilities and other meetings. Quality System Requirements:In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.