Jr. Regulatory Affairs Associate

Intellectt Inc • US, CA, Alameda • 3w ago

Role: Regulatory Affairs Associate

Location: Alameda, CA - 94502

Duration: 12 Months on W2 (possible extension)

Shift Timings: 6 AM to 2:30 PM

100% Onsite role ; It is a challenge but a requirement and I do not want to look at candidates who wish for a remote role.
After training (3 to 4 weeks), once a candidate is familiar with the team and understands the work flow, he will allow a hybrid model with 3 days onsite and 2 days remote.
Open to National Search (Relocation at own expense)

Looking For

Regulatory affair associate
Help in change management; Reviewing changes performed to labelling, manufacturing and design and regulatory impacts of those changes.
Exp or ability to review study reports for submission and may even author the submissions
Exp in a medical device environment functioning in quality, R&D or Operations
Need to understand how software works in a mobile system; Mobile software experience is a plus, but not required.
Exp. with 510K submissions a plus but not required
Must have critical thinking
Open to Master's in Regulatory Affairs with limited exp (internship or co-op) or even a Biomedical degree but, they must have exposure to 510k and can speak to that experience.
Open to Engineer degree with Quality Assurance exp, if they can display what it means to work in a regulated environment.

Education And Experience

Bachelor's degree req'd in Science or Regulatory Affairs.
Masters in Regulatory w/internship or Co-op a plus.
0 to 2 years of experience in regulatory, Quality Assurance, R&D or operations so, he/she can be a fresh grad with internship or co-op exp

Interview Process

Video screening followed by panel video interview.