Regulatory Affairs Specialist

Posting ID : A1068540163
Date Posted : 2015-08-19
Category : Science Biotech

Job Summary

The RA Specialist serves a vital role by providing support throughout various stages of product realization to ensure successful and timely product launches and product sales. This position interacts with all levels of technical and non-technical personnel both in and out-side the company. This position communicates with distributors all over the world to obtain product licensing and registrations necessary for export and sale of products globally. In providing the necessary support, this position also helps to ensure and enforce compliance with regulatory requirements as well as the quality system requirements.

Prepares reports and other technical file documentation as required to support product development, regulatory and product registration/licensing requirements.
Prepares and submits product licensing applications and updates applicable declarations and certificates.
Provides regulatory support to distributors and strategic partners in obtaining product registrations and license as necessary
Conducts reviews of data, instructions for use (IFU) and other documentation to ensure design, process, quality system, and regulatory requirements are met prior to product transfer and release.
Participates in formal design reviews, risk assessments, and post market assessment activities.
Establishes and maintains procedures for work instructions, and other forms as needed.
Performs monitoring and measuring activities as necessary for regulatory processes.
Participates in investigations as necessary for determination and implementation of corrective and preventive actions.
Participates in internal and external audits as needed. May serve as member of internal audit team.
Develops delivers technical presentations and training sessions.
Provides back-up to Document Control, Quality Assurance, and other regulatory and compliance functions.
Provides back-up to perform IHC staining for complaints, research and development, and other quality functions as required.

Job Requirements and Qualifications:
A BS/BA in a biological science or similar field with a minimum of 3 years' experience in a medical device manufacturing or related industry; or equivalent combination of education and/or experience is required.
A minimum of 2 years in regulatory affairs or related compliance field is required.
Laboratory experience in FDA regulated biotechnology or pharmaceutical environment is preferred.
Working knowledge of FDA QSRs and ISO 13485 or other related industry standards preferred.

If you meet the minimum requirements, please submit your resume through our website: .

No phone calls please.

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