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Regulatory Affairs Specialist II
2 months ago
Immediate need for a talented Regulatory Affairs Specialist II. This is a 03+ Months Contract opportunity with long-term potential and is located in Chaska, MN (Remote). Please review the job description below and contact me ASAP if you are interested.
Job ID:24-42060
Pay Range: $31 - $34/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
- The Regulatory Affairs Specialist II will support the IA business unit in meeting global registration requirements.
- As a regulatory process expert supporting global registrations the candidate interprets federal/state/international regulations as they apply to our products, processes and procedures, advises on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints.
- Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes.
- Determine the need for and prepares regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval and appropriate country licenses and certificates for new products and/or changes to existing products.
- Respond to regulatory agency inquiries.
- Knowledge of product history, profile, specifications, standards, safety issues, precedents and approval.
- Investigate regulatory history of similar products to assess approval implications.
- Meet and follow policies and procedures to complete milestones.
- Communicate with internal technical (engineers/scientists) and regulatory personnel. Interpret and evaluate data.
- Write and edit technical documents.
- Prepare and submit IVDR documentation.
- Prepare and submit Global registration documentation.
- Electronic submission process, types and requirements (CLARA). Monitor applications under regulatory review. Maintain regulatory files. Import/export requirements.
- Update and maintain paper/ electronic document archival systems.
- Determine product regulatory path or class. Evaluate design changes for regulatory filing strategies.
- Assess regulatory impact and risk.
- Develops plan for timely renewal registrations to ensure continued product supply. Communicate closely with the Headquarters on the needs and problems of registration documentation and registration test.
Key Requirements and Technology Experience:
- Key Skills: Regulatory Affairs, Compliance, Verification and validation.
- Bachelor’s degree (or foreign equivalent) in Science, Regulatory Affairs, or Engineering plus 3 -5 years of experience in the offered position or related.
- Excellent organizational skills and attention to detail.
- Strong work ethic with an ability to work independently.
- Possess an ability to read, understand, and summarize technical and scientific information.
- Ability to interpret and apply regulations to company policies and procedures.
- Demonstrated ability to review and interpret design control documentation such as verification and validation test protocols/reports, risk management reports, and product labeling.
- Pragmatic with strong problem-solving skills.
- Experience working with cross-functional product development teams to ensure regulatory compliance.
Our client is a leading Pharmaceutical Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
