Medical Device Regulatory Affairs Specialist - International Submissions

Accuray™ Inc. is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a treatment to those diagnosed with cancer. It develops and markets the CyberKnife® System, the worlds first and only robotic radiosurgery system designed to treat tumors anywhere in the body with sub-millimeter accuracy. We are currently looking for a Sr. Regulatory Affairs Specialist to become a member of our dynamic team.

Position Description Performs the coordination and preparation of document packages for regulatory submissions (US and international).Compiles all materials required in submissions, license renewal and annual registrations.  Under limited supervision, reviews critical documents to assure completeness and prepares responses to routine in-country representative or regulatory agency requests.Ensures that the content, organization and overall quality of all regulatory documentation are adequate and sufficient to meet local and/or regional regulatory requirements, commitments and agreements.Keeps abreast of regulatory procedures and changes.  May direct interaction with regulatory agencies on defined matters.Represent regulatory affairs on project teams.Develops and recommends strategies for earliest possible approvals of device license  applications.Assists the team in development of tracking documents and follow to assure submissions are completed on time.Generates departmental procedures.Ensures documents are apostilled, certified, legalized or notarized as required. Assess new and/or modified standards, regulations and/or laws and determine applicability to the organization and/or product i.e. IEC 60601. In addition, this position shall lead the project teams to ensure implementation of new or modified standards or regs.

Position Requirements Qualified applicants must have a Bachelor's Degree in a technical discipline such as Engineering, Bio-medical Engineering, Computer Science, Physics, Biology, or Chemistry, or equivalent experience.5+ years Regulatory Affairs experience in medical devices (especially products containing software and electro/mechanical components).Must have international submissions experience. Proven track record in obtaining worldwide regulatory approvals. A second language is preferred. (i.e. Japanese, Chinese, French, French, Japanese)Able to communicate effectively (verbal and written) and be proficient in Microsoft Office (Word, Excel, Access and PowerPoint)Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factorsStrong critical thinking, communication, and problem solving skills.Competence in applying scientific principles and logical thought processes in preparing regulatory documentation. Detail-oriented with ability to accomplish objectives with minimal supervision. Effective working within teams, influential, and able to negotiate to reach optimal decision.Experience with Standards (ISO, IEC, EN) and HIPPA are desirable.

Please make sure your resume details your medical device RA and International Submission experience.  Please use the apply feature on Monster or note job-number MST.211.009i and email your resume to:

jobs@accuray.com