Kelly Science & Clinical is working with a growing Medical Device company in Fremont, CA looking for a talented Regulatory Affairs Manager.
Title: Regulatory Affairs Manager
What will you be doing?
- Develop regulatory processes and SOPs in compliance with international and domestic regulations
- Assist with product lifecycle planning for development of new and existing products
- Develop international regulatory strategy and oversee submission requirements
- Oversee domestic and international regulatory submissions and manage relationships with regulatory authorities
- Stay up to date on local and international regulations
- Prepare and review analytical and clinical protocols to ensure appropriate data is collected for filing submissions
- Participate in risk management activities
- Bachelor’s Degree in Biological Sciences or equivalent scientific degree
- At least 7 years of regulatory affairs experience within medical device companies
- Thorough knowledge and understanding of US and International Regulations; including 21CFR, ISO 13485
- Strong written and oral communication skills
- Excellent organization and planning skills
Apply today for immediate consideration!
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.
To Apply: https://www.jobg8.com/Traffic.aspx?DvjDPTF85WzputAMgGRpRwj