Intellectt Inc
Regulatory Affairs Specialist
Location:
Plymouth, MN – 55442
Duration:
12 Months (W2 Contract)
Key Responsibilities
Prepare, compile, and review regulatory submissions for new products, changes, and renewals to support global market access (e.g., 510(k), Technical Files, EU MDR documentation).
Maintain regulatory compliance by tracking changes to regulations and standards impacting Abbott’s products.
Support labeling reviews, change assessments, and risk management documentation.
Collaborate with cross‑functional teams including R&D, Quality, and Manufacturing to ensure product documentation aligns with applicable regulatory requirements.
Assist in responding to regulatory agency requests for additional information and support audits or inspections.
Maintain accurate records and documentation in compliance with FDA 21 CFR 820 and ISO 13485.
Participate in design control activities and support regulatory strategy for product development projects.
Provide guidance to teams on global regulatory requirements, including US FDA, EU MDR, and international submissions.
Required Qualifications
Bachelor’s degree in a scientific, engineering, or regulatory discipline.
Minimum 2 years of experience in Regulatory Affairs within the medical device or pharmaceutical industry.
Strong understanding of US FDA, EU MDR, and ISO 13485 regulatory requirements.
Experience with 510(k) submissions or other regulatory filings.
Excellent organizational, analytical, and communication skills.
Ability to manage multiple projects in a fast‑paced, cross‑functional environment.
Preferred Qualifications
RAC certification or equivalent regulatory training.
Experience with labeling compliance, risk management (ISO 14971), and document control systems (Agile, Windchill).
Prior experience working with Class II or Class III medical devices.
Seniority Level:
Associate
Employment Type:
Contract
Industries:
Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research
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Plymouth, MN – 55442
Duration:
12 Months (W2 Contract)
Key Responsibilities
Prepare, compile, and review regulatory submissions for new products, changes, and renewals to support global market access (e.g., 510(k), Technical Files, EU MDR documentation).
Maintain regulatory compliance by tracking changes to regulations and standards impacting Abbott’s products.
Support labeling reviews, change assessments, and risk management documentation.
Collaborate with cross‑functional teams including R&D, Quality, and Manufacturing to ensure product documentation aligns with applicable regulatory requirements.
Assist in responding to regulatory agency requests for additional information and support audits or inspections.
Maintain accurate records and documentation in compliance with FDA 21 CFR 820 and ISO 13485.
Participate in design control activities and support regulatory strategy for product development projects.
Provide guidance to teams on global regulatory requirements, including US FDA, EU MDR, and international submissions.
Required Qualifications
Bachelor’s degree in a scientific, engineering, or regulatory discipline.
Minimum 2 years of experience in Regulatory Affairs within the medical device or pharmaceutical industry.
Strong understanding of US FDA, EU MDR, and ISO 13485 regulatory requirements.
Experience with 510(k) submissions or other regulatory filings.
Excellent organizational, analytical, and communication skills.
Ability to manage multiple projects in a fast‑paced, cross‑functional environment.
Preferred Qualifications
RAC certification or equivalent regulatory training.
Experience with labeling compliance, risk management (ISO 14971), and document control systems (Agile, Windchill).
Prior experience working with Class II or Class III medical devices.
Seniority Level:
Associate
Employment Type:
Contract
Industries:
Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research
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