Regulatory Affairs Specialist II
ArthroCare Corporation - Austin, TX

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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 submissions (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 required.

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 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

ArthroCare Corporation - 22 months ago - save job - copy to clipboard
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