Sr Regulatory Affairs Specialist
Sr. Regulatory Affairs Specialist
Greater Dallas TX Area
Be a part of an elite team where your communication with management is direct, your process is streamlined, and the impact you have is significant! As a leading global innovator, developer, manufacturer and marketer of specialty medical devices, surgical implants and powered surgical instruments, this team has a tremendous effect on the health of thousands of patients. You can make a difference! Come contribute to the goal of changing people’s lives!
Looking for a self-starter, manage complex projects/products, including responsibility for the content, assembly, pre-final review, and filing of major medical device applications (e.g., IDE’s, PMA’s, 510(k)’s) submitted to the FDA and foreign regulatory agencies. Applies regulatory expertise to evaluation and solution of product development issues.
BA/BS or MS degree in Scientific or Technical Discipline
CQA, or RAB Certifications a plus
4+ years of experience in FDA-Regulated Industry
Skills, Knowledge, and Abilities:
- IDE,PMA,510(k) and CE Submissions
- Ability to independently analyze and interpret novel clinical, medical and scientific data.
- Current knowledge of current US FDA and global regulatory requirements within the medical device industry.
- Strong analytical, management, communication and interpersonal skills. Good knowledge of MS Office, internet, and databases.
- Excellent writing skills and the ability to write scientific summaries.
- Must have the ability to handle multiple assignments and perform in a diverse cross-functional team environment.
*** Competitive Benefits Package! ***