Regulatory Affairs & Compliance Lead - Biologic Products

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POST DATE 8/26/2016
END DATE 12/19/2016

Diedre Moire Corporation, Inc Durham, NC

Durham, NC
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #


Seeking extensive Regulatory Affairs and Compliance specialist to lead the group responsible for:

*** FDA submissions and compliance for: promotional literature, registrations, licenses, regulatory filings including 510(k), PMA (premarket approval), IND (investigational new drug application), BLA (biologic license applications), etc.

*** Interfacing with regulatory agencies including the FDA CBER (Center for Biologics Evaluation and Research).

*** Initiating internal audits and meeting with outside agencies for regulatory and compliance audits.

*** Maintaining registrations and licenses for federal, state, and local requirements.

*** Evaluating, understanding, and updating products based on international registration requirements.

*** Investigating, reporting, and otherwise handling adverse events.

*** Creating, implementing, maintaining, and updating SOPs.

Must have experience in a Regulatory Affairs, Quality Assurance, Compliance, or similar role within a medical device company, biopharmaceutical company, diagnostic product company, or similar.

Additional opportunities in Florida with option to relocate to the "Sunshine State" where the weather is warm and sunny year round, the golf courses are immaculate, the oranges are always fresh, and the weekend activities are practically endless!

Generous salary to $115,000 with competitive performance based bonus, full medical coverage and benefits including family dental, vision, prescription drugs, doctor visits, etc. Join a growing company in an emerging market where the career growth and learning opportunities are fantastic. Long-term upwards mobility with internal promotion potential, annual two-way reviews, and more! Company features competitive 401(k) pension with dollar-for-dollar matching plan, non-monetary incentives, paid time off - including vacations, holidays, personal days, etc. - and more!

Please reference #36898179 when responding.

Education Requirements: Bachelor Degree
Minimum Experience Requirements: 5-10 years
Job City Location: Durham
Job State Location: NC
Job Country Location: USA
Salary Range: $65,000 to $115,000

WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, sex, national origin, handicap, disability or marital status. We reasonably accommodate individuals with handicaps, disabilities and bona fide religious beliefs.