- Working on cross functional teams and communicating complex regulatory requirements and technical data in an understandable way for any audience.
- Managing multiple applications simultaneously and interfacing directly with regulatory bodies, agencies, distributors and other stakeholder to resolve application issues.
- Authoring and compiling technical documentation for submissions, licensing and re-licensing, and change reporting.
- Researching and reporting relevant regulations and conducting impact/gap analyses to ensure smooth implementations in assigned markets.
- Supporting in Regulatory Agency audits and assisting with other regulatory compliance duties as assigned to department.
- 5+ year's global experience in a Regulatory Affairs role at a Medical Device manufacturer.
- Bachelor's degree minimum
- Excellent writing skills, in global technical file and submission documents.
- Ability to work in a fast-paced environment managing multiple projects / countries.
- Working knowledge of ISO 14971.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.