Principle Regulatory Affairs

Posted: 9/16/2019 10:13:22 PM

Job Snapshot

Location: Sunrise, FL, US
Posting ID: 6934573

Job Summary



Responsibilities
  • Develop medical device regulatory submissions in accordance with FDA requirements (e.g., pre-submissions, original IDEs, IDE supplements, 6-month Investigator Lists, original PMAs, PMA supplements, IDE/PMA Annual Progress Reports, 510(k)s, MAFs)
  • Develop Design Dossiers and Technical Files for CE marking purposes
  • International regulatory submissions as required
  • Review and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations. Review, edit and provide regulatory and quality system approval for project documentation.
  • Review and analyze technical protocols, data, and reports generated by Research and Development, Operations, Clinical Research, Quality Assurance or other related departments.
  • Participate in the development of world-wide regulatory strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products.
  • Partner with cross functional teams by providing independent regulatory guidance and support to product development teams for strategic planning, design and development, and compliance activities.
  • Respond to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals in other countries, as well as provide routine regulatory information to associates and affiliates.
  • Review and provide regulatory authorization for Nonconformance reports (NCR)
  • Prepare and file facility registration documents
  • Prepare the necessary documents to obtain Certificates of Exportability and Certificates to Foreign Government from US FDA


Requirements
  • International regulatory experience required
  • 5 plus year's experience in regulatory affairs for medical device companies or pharmaceuticals
  • 510k submissions


Enviornment
  • cGMp environment/office based










About Aerotek:

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.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Skills

new product development
quality assurance
marketing
documentation
advertising
packaging and labeling
research and development
authorization (medical)
strategic thinking

About CareerCircle

The statistic has gone viral that there will be a talent shortage of 85.2M people by 2030. CareerCircle was founded in the spirit of finding solutions to address the pending skills gap versus falling victim to it. With so many capable people wanting to find employment and employers needing partners to achieve their goals, CareerCircle is here to provide a bridge.

At CareerCircle, we recognize that CareerskillingTM is the fastest path to improved performance and securing your ideal role. To advance your skills, you need access to the highest caliber of online education technology that is delivered in a meaningful way. Here is where we come in. We partner with experts in education technology to deliver unique learning experiences that can be instructor-led or self- paced, supplemented with the necessary support for optimal results. By completing the coursework provided by these groups, candidates gain the ability to be marketed to recruiters and potential employers with an emphasis on acquired skills and performance, versus limited work history or listed resume experience. In the end, your journey of advanced education leads to higher pay, flexibility, and a better life.

Contact Information

Name: Nicolas Pardo
Phone: (954) 717-3547