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:
Supervisory Responsibilities: None.
- 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.
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:
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.
- 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.
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Equal Opportunity Employer
ArthroCare Corporation - 2 years ago