Regulatory Affairs Specialist IV-CA

2 weeks ago


California, United States Global Recruiters of West Palm Beach Full time

Required Experience: Minimum 4-6 years industry experience with 2-3 year experience in preparation and submission of 510k and CE technical files.

Required Education: Bachelors in related discipline or equivalency;

Job Description

As a global leader in medical diagnostics and life sciences, our client is seeking a Regulatory Affairs Specialist IV for its Southern CA location. Our client is committed to expanding their OTC and laboratory/hospital diagnostics products, including point-of-care COVID, blood glucose testing, pregnancy and a number of other POC/OTC tests. The company has led in making high quality diagnostic and medical devices more affordable to people all around the world, providing exceptional value for millions of Americans with COVID, diabetes and other metabolic disorders.

The Regulatory Affairs Specialist IV will support the company’s worldwide product registrations and Regulatory activities, which includes the coordinating the accumulation of technical information and prepares submissions for therapeutic, medical, or diagnostic device licenses to various governmental regulatory agencies by performing the duties including but not limited to below.

Knowledge & Skills

Key Duties, Activities and Responsibilities:

• Drafts, edits, and compiles technical files and design dossiers in support of EU/UK regulatory fillings; • Participates in new product development core teams and creating of Regulatory Strategies, and representing RA function group participation of products design phase review from I to V and provide regulatory consideration to the design team regard to design RA requirement and guidance document; • Maintains country specific site registration requirements; • Prepares the submit files for US 510k submission and CR registration • Assists in preparing documentation for product incident reporting as required; • Assists with the preparation of annual surveillance reports on approved products. • Maintains current regulatory knowledge by attendance at regulatory seminars and meetings; • Maintains current regulatory databases to produce various reports as needed; • Review labeling, package inserts, promotional materials and company website to meet the FDA regulatory requirements; • Maintain Essential Requirements Checklists- ensuring that applicable standards are utilized and updated as revisions are introduced; • Compile Technical Documentation for historical files; • Assist OEM customer in obtaining the CE mark on their products.

Work Experience, Skills and Education Required: • Bachelors in related discipline or equivalency; • Minimum 4-6 years industry experience with 2-3 year experience in preparation and submission of 510k and CE technical files. • Strong working knowledge of medical devices regulations and terminologies; • Excellent written and oral communication, and technical writing and editing skills; • Ability to write clear, understandable technical documentation; • Skilled at analyzing and summarizing data; • Proficient with Microsoft Office; • Ability to manage and prioritize multiple projects; • Ability to follow written and verbal direction with a high level of accuracy; • Ability to work in a team setting; • Knowledge of QSRs & ISO 13485; IVDD/IVDR, MDD/MDR, UK MDR 2002, CMDR, GMP, and 21 CFR.

GRN West Palm Beach

9897 Lake Worth Road, Suite 202 Lake Worth, FL 33467 USA

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