Regulatory Compliance Specialist

Regulatory Affairs Associate Alameda, CA Must be able to work on a W2 LOCATION: ALAMEDA, CA 100% ONSITE
DURATION: 6 MONTHS FROM START DATE WITH POSSIBLE EXTENSIONS AFTER 6 MONTHS.
Nature of Role and Must haves: Person will review and assess regulations from various countries for business compliance.
They should have an understating of the consequences if the regulatory compliance is not met by certain dates
Must be able to review and understand regulations with a high level of proficiency.
Will review, assess, and/or approve regulatory documents and initiate the process to close gaps where needed.
Will work with other cross-functional team members in the review of regulations.
Uses a Quality System for documenting regulatory reviews.
Assesses the regulatory impact on cross-functional teams, R&D, Quality, Bio Compatibility, Manufacturing, and Supply Chain. etc.
Experience needed/required is 2 to 4 years + in the review and assessment of regulations is a must. Understanding of EUMDR, CFR 820.30, Medical Device Design Controls, Combination devices etc.
Experience in Med Device or IVD (In Vitro Diagnostic) products.
Education: bachelor's degree in Computer Science, Mechanical Engineering, Biomedical Engineering or Electronics works well for this type of work.
Top 3 Skills Needed/looking for:
o Experience in the review of Regulations & Assessing Impact to the organization/business.
o Ability to Influence Cross-Functional Teams.
o Critical & Analytical Thinking.