Remote Regulatory Affairs Submissions Specialist
- Fully remote, medical device and international submission experience preferred but will consider any candidate with pharma submissions experience
- Coordinates and prepares document packages for regulatory submissions for new and mature products.
- Compiles all materials required in submissions, license renewal and annual registrations.
- Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance.
- Monitors and improves tracking and control systems.
- Keeps abreast of regulatory procedures and changes.
- Recommends strategies for earliest possible approvals of clinical trials applications.
- Documents appropriate regulatory strategies for new products and initiate necessary activities by working with various functional teams as needed
- Assists with product submissions globally, remaining current with local regulation changes
- Supports cross-functional teams by providing appropriate regulatory procedures for new projects
- Reviews regulatory requirements from other departments for new product designs or changes to existing designs
- Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry
- Organizes all regulatory pre-market submissions and other pre-market filings to ensure appropriate commercial distribution clearances are acquired
- Supports product import by providing applicable regulatory documentation and certificates
- Performs other duties as assigned
Required Skills / Capabilities
- Basic understanding of regulatory requirements throughout the product lifecycle
- Understanding of regulatory terminology, pre-market submission types, and requirements
- Able to evaluate the regulatory impact of proposed product and process changes
- Multi-tasking skills with the ability to project plan and meet deadlines
- Result driven with a sense of responsibility, urgency and ability to perform under pressure
Education and Experience
- Typically requires a Bachelor s degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience 2+ years of related experience in the medical device industry
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.
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