In this role you will:
- Direct or perform coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
- Lead or compiles all materials required in submissions, license renewal and annual registrations.
- Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Monitor and improves tracking / control systems.
- Keep abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters.
- Recommend strategies for earliest possible approvals of clinical trials applications.
IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME
BA or BS Degree
• Minimum of 4 years regulatory affairs, quality or engineering experience with Bachelors
• Minimum of 2 years regulatory affairs, quality or engineering experience with Masters
• Minimum of 0 year(s) regulatory affairs, quality or engineering experience with Doctorate
• In depth experience with FDA requirements, guidance documents, 510(k) submissions, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements
• History of successful device submissions
• Strong negotiation skills and written/oral communication skills.
• Effective interpersonal skills, self-motivated, collaborative
• Ability to comprehend principles of engineering, physiology and medical device use. Critical thinker
• Strong organizational skills and time management skills
• Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines