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.

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Equal Opportunity Employer

ArthroCare Corporation - 2 years ago - save job
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