Global Regulatory Compliance Data Analyst

6 days ago


San Jose, California, United States MILLENNIUMSOFT Full time

Job Title: Global Regulatory Compliance Data Analyst (Mathematics Knowledge)

Location: San Jose, CA

Duration: 12+ Months

Client: Medical Device Company

Job Category: Research & Development

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1Bs

Work hours: 40hr/ week

Remote for now, but will be expected onsite once site opens. Must be local


Top 3 Skills/Qualifications

Preferred mathematics knowledge.

Familiarity working with large data set collection and management.

Basic understanding of chemistry

Product Stewardship Data Analyst

Job Summary:

The Global Regulatory Compliance Data Analyst will collect, analyze, review, chart, enter global UDI attributes, global labelling information and global Regulatory Compliance Data information into predefined system. This position is responsible for aggregating, submitting and maintaining UDI databases which include various product data.

Additional position key elements are to provide detailed analysis, evaluation and recommendations for both UDI and Regulatory Compliance systems and process improvements, organizational development and maintenance efforts for critical challenges or issues.

Duties And Responsibilities:

With supervision, participates in determination of percent composition of final and intermediate reagents as required.

Basic math/chemistry skills are required, and general knowledge of reagent process flow and SAP navigation is desired but not required.

Ensures timely and relevant development for strategies driving data attribute collection, management, entry, storage and global submission.

Compile data from multiple sources and perform report analysis in excel sheet.

Identify issues with data, gap analysis and coordinate with Product Stewardship team to ensure data standards are being maintained, identify the required changes and their priority.

Ensures that all standard data entries and summaries are statistically valid. Assists and educates users in running and interpreting results from relevant databases and reports.

Responds to internal and external requests for data through the preparation of ad-hoc queries and reports.

Collaborates with multiple stakeholders across the businesses to share project status.

Experience with key Global Regulations:

Knowledge of UN GHS (Global Harmonized System), Registration Evaluation Authorization and Restriction of Chemicals (REACH), Classification, Labelling and Packaging (CLP) Regulation (EC) No 1272/2008), Occupational Safety and Health Association (OSHA), Workplace Hazardous Material Hazardous System (WHMIS), California Proposition 65 (Cal Prop 65), European Union's (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Good communication skill, both verbal and written.

Able to perform multiple activities in a fast-pace environment.

Able to perform calculation on formula composition.

Qualifications:

BS or BA degree in a technical, scientific, management, packaging, writing or related discipline, and minimum of 3-5 years of experience in a related field is required.

Knowledge of relevant PC software applications and possesses ability to work independently on such programs.

Preferred mathematics knowledge.

Must have familiarity working with large data set collection and management.

Effective communication skills, oral and written.

Demonstrated ability to influence others (beyond direct reports).

Demonstrated ability to effectively handle multiple project priorities.

Excellent organization & prioritization skills.

Demonstrated problem solving skills.

Demonstrated ability to lead dynamic work teams across functions and business units.

Project management/facilitation skills.

Excellent follow-up and documentation skills.


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