Our #FDAFriday series has focused on some of the various roles at FDA from former FDA employees. Well, what if we told you FDA is looking to hire you!?
In one of AcKnowledge RS’ first blog posts (woah, I just checked and that was almost 2 years ago!), I talked about how I got into Regulatory Affairs (RA). In that post I discussed some options and suggestions for people who might be trying to do the same. To recap, there are several different ways you can break into RA, namely by checking local and national resources, by taking regulatory courses offered online or at certain universities, and most importantly, networking! But FDA is taking it one step further and making it even easier to cut your teeth on one of the coolest career paths out there.
Many device companies offer “hands-on” internships during the summer, which is a great opportunity for college students on summer break and recent graduates who are looking for some summer experience. The Office of Device Evaluation (ODE) at FDA just announced one such internship program. ODE, at the Center for Devices and Radiological Health (CDRH), is the part of the FDA that is responsible for the review and regulation of new medical devices before they are introduced into the marketplace.
The Device Evaluation Intern Program is the internship program that allows college-aged students to receive some experience in the field, and is offered year-round. When it comes down to the end, the program settles on 4-5 selected interns to participate in the program. The FDA also has a program that is designed specifically and primarily for students and recent graduates, and is called the Federal Pathways Program. Any and all applicants are encouraged to apply through the usajobs website (see links below).
ODE describes the internship opportunity as follows:
“Our Intern Program can be a challenging and rewarding experience for individuals interested in pursuing careers in the fields of science, engineering, and/or medicine. You will be given the opportunity to test your educational interests in a practical work environment, gain entry level professional "real work" experience, work alongside some the Agency's top healthcare authorities, establish professional contacts and most importantly, have a learning experience of a lifetime.”
FDA writes that the duties and responsibilities of the intern include:
- Obtain and review technical literature or data to determine the safety, efficacy, and degree of risk to the public health of medical devices;
- Perform administrative duties associated with device submissions, write minutes of technical and administrative discussions held between division personnel, industry, and management;
- Assist senior reviewers in obtaining and reviewing technical data and material related to medical device submissions (510(k)s, IDEs, and PMAs);
- Perform literature searches for senior scientists and prepare summaries;
- Assist in preparing correspondence regarding informal inquiries about various types of medical devices.
The intern will get opportunities to participate in meetings, lunch seminars, and intern get-togethers. What a great opportunity to work at FDA!
So, how do you apply to the program? Apply through the http://www.usajobs.gov/ website. Your application should include a cover letter with a summary of your interests in the medical device area. You can mention all the cool stuff about medical devices you’ve learned over here on the AcKnowledge RS blog!