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!

For details contact Branden F. Lynch at:
(609) 584-9000 ext 241

Or submit resume online at:
http://dmc9.com/bfl/app.asp

Or email to:
1000024401_10007337@jobbank302.com

Please reference #36898179 when responding.

5+ years

North Carolina

$65,000.00

$115,000.00

Branden F. Lynch

(609) 584-9000 ext 241

1000024401_10007337@jobbank302.com

http://dmc9.com/bfl/app.asp

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. Jobs Career Position Hiring. CONSIDERED EXPERIENCE INCLUDES: http://najobbank.com www.najobbank.com Top 10 Job Site Top 10 Careers Site Quality Compliance Specialist Regulatory Affairs Product Quality Engineer Quality Specialist Regulatory Engineer Medical Device Products Nerve Repair Reconstruction Surgical Device Graft Extracellular Matrix ECM Diagnostic Product Testing System Pharmaceutical Biotechnology Biotech FDA Food and Drug Administration 21 CFR 820 ISO 9000 ISO 13485 Tissue Bank 510k 510(k) 21 CFR 1271 GTP Good Tissue Practice Biologic CBER Center for Biologics Evaluation and Research Statistical Analysis Xenotransplantation

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