Regulatory Affairs Specialist II - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
About the Job
Responsibilities:
Requirements:
- 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. Job Duties: 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.
Requirements:
- Bachelor's degree (or foreign equivalent) in Science, Regulatory Affairs plus 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. 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.
Source : Katalyst Healthcares & Life Sciences
