International Regulatory Affairs Specialist II

ArthroCare Corp. (Nasdaq:ARTC) is a multi-business medical device company that develops products based on its pioneering Coblation(R) technology. The benefits of Coblation technology provide an answer to the challenges of soft tissue management in any surgical specialty where controlled and efficient ablation is of value. Current applications include: Arthroscopic Surgery, Spine Surgery, Dermatologic Surgery, Ear, Nose & Throat Surgery (ENT), and General Surgery.

Our greatest achievements come from our greatest assets: ArthroCare's employees. We are continuously seeking new talent to join ArthroCare's winning ranks. People who thrive at ArthroCare are passionate about improving surgical procedures and patient outcomes, have a competitive spirit and winning attitude, and place a high value on teamwork and trust. We offer a competitive benefits package and excellent opportunity for career development.

Summary: Prepare and submit international product registration documentation for medical devices. Serve as liaison for all non-Us regulatory agencies, distributors and marketing groups in support of new product introductions as well as day-to-day international regulatory compliance for existing products.



Essential Duties and Responsibilities include but are not limited to: (Other duties may be assigned)Prepare and submit international product registration documentation for various classes of medical devices to Canada, South America, Asia and Australia. Communicate international regulatory requirements to product development product development teams and US regulatory personnel.Maintain system/procedures for developing and updating registration documentation in support of internationally marketed products.Ensure product export requirements (e.g. Certificates to Foreign Governments) are met and related activities are coordinated. Monitor activities of applicable international regulatory agencies and industry organizations to identify any changes in regulations and communicate appropriate personnel. Provide regulatory support to international office.Provide support to Complaint Handling activities within the Regulatory Affairs Department



Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required.



Education and/or Experience:Requires a bachelor’s degree and 3-5 years of medical device industry experience.Solid working knowledge of international regulatory requirements, particularly Canada and Asia. Ability to manage relationships with international regulatory agencies, distributors, marketing and product development personnel. High level of attention to detail. Understanding of FDA Quality System Regulation (QSR) and ISO 13485 standard. Must have excellent verbal and written communication skills.Ability to work effectively as a member of a team.



Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the functions of the job.



For consideration of this and other opportunities please visit our career center at http://careers.arthrocare.com



Equal Opportunity Employer

www.ArthroCare.com



Education: BachelorsJob Level: 3-5 Years