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Regulatory Affairs Specialist-east Coast

3 weeks ago

East Coast, Singapore Global Recruiters of West Palm Beach Full time

**A global clinical diagnostics firm that is dedicated to the continuous development of an expanding menu of assay/instrumentation systems that aid in the detection of antibodies and diseases associated with Autoimmune and Infectious Diseases. The company is seeking Regulatory Affairs Specialist for its East Coast. Their expertise lies in providing diagnostic solutions for various medical conditions, including hematology, oncology, and metabolic disorders. Their product portfolio includes instruments, reagents, and software designed to assist healthcare professionals in accurately diagnosing and monitoring patients care worldwide. The company is seeking Regulatory Affairs Specialist for its East Coast.**

**The Regulatory Affairs Specialist will support the company’s US product registrations and Regulatory activities, which includes the coordinating the accumulation of technical information and prepares submissions for 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.**

**A global clinical diagnostics firm that is dedicated to the continuous development of an expanding menu of assay/instrumentation systems that aid in the detection of antibodies and diseases associated with Autoimmune and Infectious Diseases. The company is seeking Regulatory Affairs Specialist for its East Coast. Their expertise lies in providing diagnostic solutions for various medical conditions, including hematology, oncology, and metabolic disorders. Their product portfolio includes instruments, reagents, and software designed to assist healthcare professionals in accurately diagnosing and monitoring patients care worldwide. The company is seeking Regulatory Affairs Specialist for its East Coast.**

**The Regulatory Affairs Specialist will support the company’s US product registrations and Regulatory activities, which includes the coordinating the accumulation of technical information and prepares submissions for 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