Regulatory Affairs Associate in Alameda, CA

Summary

• One of the key aspects of this role is to be able to review and assess the regulation and also be able to identify how it impacts business. So can use the keyword search "compliance" " assessment" to assist in finding these candidates.

Must have ~ Person will review and assess regulations from various countries for business compliance.

• Must have ~ They should have an understanding about the consequences if the regulatory compliance is not met by certain dates
• Must have ~ Must be able to review and understand regulations with a high-level of proficiency.
• 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.

Duties

• Must have ~ Person will review and assess regulations from various countries for business compliance.
• Must have ~ They should have an understating about the consequences if the regulatory compliance is not met by certain dates
• Must have ~ 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, 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: Bachelors degree in Computer Science, Mechanical Engineering, Biomedical engineering or Electronics works well for this type of work.

Top 3 Skills Needed/looking for:

• Experience in the review of Regulations & Assessing Impact to the organization/business.
• Ability to Influence Cross-Functional Teams.
• Critical & Analytical Thinking.

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