Director, Regulatory Compliance Consulting – Sanctions
CNA Insurance
Sr. Regulatory Affairs Program Manager
Medtronic
full-time
Posted on:
Origin: • 🇺🇸 United States • Colorado
Visit company websiteSalary
💰 $154,400 - $231,600 per year
Job Level
Senior
About the role
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.\n
- Leads or compiles all materials required in submissions, license renewal and annual registrations.\n
- Oversees and/or conducts comprehensive reviews of promotional materials.\n
- Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.\n
- Monitors and improves tracking / control systems.\n
- Keeps abreast of regulatory procedures and changes.\n
- May direct interaction with regulatory agencies on defined matters.\n
- Recommends strategies for earliest possible approvals of clinical trials applications.\n
- Autonomy: Manages one or more medium-scale, established programs with generally-defined program plans and delivery methodologies.\n
- Organizational Impact: Participates in establishing program objectives, timelines, milestones, and budgets.\n
- Innovation and Complexity: Problems and issues faced are difficult and undefined, requiring detailed information gathering, analysis and investigation.\n
Requirements
- Requires broad management knowledge and experience to lead project teams in one department.\n
- Typically has mastery level knowledge and skills within a specific technical or professional discipline with broad understanding of other areas within the job function.\n
- Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience.
