Regulatory Affairs Specialist

Under general direction, will oversee Regulatory, Quality Assurance & Compliance and develop and implement department goals, objectives, and systems to ensure compliance with Quality System regulations established by internal procedures, the US FDA and applicable international regulatory bodies and/or standards.
Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation), and 21 CFR Part 11 (Electronic Records; Electronic Signatures). ISO 13485 Medical Device Directive, and the Canadian Medical Device Regulations, and the Australian Therapeutics Goods Administration regulations (as applicable) at an advanced level.
• Knowledge of regulatory submissions (IDE, 510(k), etc.).
• Ability to develop effective quality systems and regulatory strategies and programs.
• Ability to demonstrate excellent organizational, leadership, reasoning, judgment, and interpersonal skills.

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of the job, the employee is regularly required to sit; talk and hear;

use one or both hands to finger, handle or feel; use a simple grasp; and occasionally required to stand, walk, grasp with one or both hands; and to lift and/or move up to 10 lbs. Normal 20/20 vision ability (with corrective lenses, if needed) is required by this position. The noise level in the work environment is somewhat quiet.

Required Experience:

Bachelor’s degree (B.S.) from four-year college or university; and ten years as managerial experience in quality assurance and/or regulatory experience in manufacturing medical devices; or equivalent combination of education and experience. Advanced degree and experience in the medical device manufacturing quality assurance area preferred.

All your information will be kept confidential according to EEO guidelines.