Regulatory Affairs Associate

Hi,

Hope you are doing good,

This is Kalpana Recruiter from intellect, we have openings for Senior Regulatory Affairs Specialist at with our Direct client in the location Franklin Lakes, NJ if you are looking for any job change, please check the job description and let me know if you are interested. you can reach me out at kalpana@intellectt.com or please call me at 732-832-3282

Role: Senior Regulatory Affairs Specialist

Duration: 12 Months (Possibility of temp to perm)

Job Location: Franklin Lakes, NJ

Role Type: Need to be onsite 2 to 3 days a week. Hybrid. (need to be onsite on Mon & Tues, 3rd day is flexible. Hours are also flexible and not fixed to 9 to 5 as groups is working with international teams. So candidates need to be able to take early or late calls in mornings or evenings depending on teams and adjust schedule accordingly). Team quite often works with teams in Asia, France etc.

Project: Regulatory candidate - focused on one product but must sell in different markets. Must have good understanding of international regulations.

Will work on post market regulatory submissions.

Day to day life includes candidate will review regulatory changes and assessments. Support international submission requirements. Coordinate with global teams to make submissions. Coordinate with suppliers of multiple markets.

Top 3 Must Haves

Being able to communicate with customers in a professional manner. Role requires a lot of coordination with global teams.

Being able to perform regulatory assessments.

Need to have general device knowledge and experience.

Skills Looking For

Should be able to Multitask.

Should be able to communicate with health authorities in a professional manner.

Education & Experience

Minimum of Bachelor's degree is needed in a technical discipline (e.g., pharmacy, engineering, biology, chemistry). Advanced degree preferred.

Need to have at least 5+ years of global regulatory experience in Medical device. (Experience in Pharma and Biologics is also considered).

Interview

2 rounds of video conference interviews with hiring manager followed by a panel.