Manager of Regulatory Affairs or Senior Regulatory Affairs Specialist


Lehigh Valley, PA

Industry: Healthcare


Less than 5 years

Posted 229 days ago

  by    Cari Kraft

This job is no longer available.

 Our client, a leading surgical medical device company is looking to hire a Senior Regulatory Specialist OR Regulatory Affairs Manager level to join their team in PA. Full relocation package provided for home owners and renters!


This person will be responsible for preparing and submitting 510(k)s, PMAs and IDEs (US and globally), to ensure marketing approval of their Class II Medical Devices.

Must have:


?        3+ years Regulatory Affairs experience in medical devices, preparing and submitting/filing 510k (s) from beginning to end

?        Authorization is a plus

?        Must have FDA interaction experience

?        Must be able to work independently

?        Domestic experience


Company offers:

?Stellar Benefits Package

?Full relocation package



$92K - $115K
$80K - $100K base, excellent benefits bonus