Regulatory Affairs Specialist II
Location: Austin Texas
Description: ArthroCare Corporation is employing Regulatory Affairs Specialist II right now, this job will be placed in Texas. Detailed specification about this job opportunity kindly read the description below. Location: Austin, Texas
ArthroCare Corporation (Nasdaq: ARTC) - founded in 1993 is a highly innovative, multi-business medical device company that develops, manufactures a! nd markets minimally invasive surgical products. With these products, ArthroCare targets a multi-billion dollar market opportunity across several medical specialties, significantly improving existing surgical procedures and enabling new, minimally invasive procedures. Many of ArthroCare’s products are based on its patented Coblation technology, which uses low-temperature radiofrequency energy to gently and precisely dissolve rather than burn soft tissue â€" minimizing damage to healthy tissue. Used in more than four million surgeries worldwide, Coblation-based devices have been developed and marketed for sports medicine; spine/neurologic; ear, nose and throat (ENT); cosmetic; urologic and gynecologic procedures. ArthroCare also has added a number of novel technologies to its portfolio, including Opus Medical sports medicine, Parallax spine and Applied Therapeutics ENT products, to complement Coblation within key indications.
Our greatest achievements come from! our greatest assets: ArthroCare's employees. We are conti! nuously 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: Under a moderate degree of management supervision and direction, assists in developing global regulatory strategy and coordinating associated registration or submissions leading to market clearance/approval, providing regulatory direction to project teams for product development/design control related activities, assessing various change notices for regulatory submission impact and developing product labeling.
Essential Duties and Responsibilities include but are not limited to: (Other duties may be assigned). Under a moderate level of management supervision and direction: Prepares regulatory su! bmissions (e.g., 510k’s, CE Technical Files, international registrations) leading to timely market introduction. Develops preliminary regulatory strategies for key global markets in support of new product development activities. Participates with immediate supervisor on product development teams to provide input and support related to the registration review process, registration requirements and timelines. Monitors activities of applicable regulatory agencies and industry organizations to identify any changes in regulations. Provides immediate supervisor with preliminarily review and assessment of change notices (e.g., ECN’s) for impact on existing product submissions and registrations. Assists with development of product labeling, including Instructions for Use.
Supervisory Responsibilities: None.
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 requi! red.
Education and/or Experience: Requires a Bachelor’s Degree (preferably in a clinical, medical, scientific/technical or legal discipline) and a minimum of 2 years of prior related medical device industry experience or equivalent. Requires a high level of computer proficiency (Adobe, MS Office, etc.). Possesses appropriate verbal and written communication skills for interacting with internal and external stakeholders. Demonstrates a solid, fundamental understanding of medical terminology, anatomy, regulations, standards and technical concepts. Able to work and problem solve both independently and as part of a team. Able to work within deadlines as imposed by government regulations and internal guidelines. Able to handle multiple tasks/projects and demonstrate flexibility in managing changing priorities. Able to read, understand, and apply regulations to ArthroCare activities.
Physical Demands: The physical demands described here are repre! sentative 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
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If you were eligible to this job, please email us your resume, with salary requirements and a resume to ArthroCare Corporation.
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This job starts available on: Wed, 08 May 2013 22:25:32 GMT