Regulatory Clinical Specialist II

Overview

The person in this position will provide support to the Regulatory Affairs department at Cook Biotech Incorporated (CBI). They will prepare regulatory submissions with focus on clinical writing to obtain and maintain market approval of CBI’s products globally. May also interact and correspond with international regulatory agencies and/or external Cook partners. Career Grid II.

Responsibilities

• Author high-quality regulatory documents for purpose of gaining and maintaining regulatory approvals with primary focus in scientific or clinical writing.
• Take a supportable and defensible position on regulatory matters and write with compelling logic and in a style appropriate for the target audience (physicians, patients, public or regulators).
• Prepare, update, and review clinical evaluation documents throughout the lifecycle of the products.
• Keep up to date with relevant legislation and guidance, including preparation and updating appurtenant, relevant regulatory instructions in compliance with regulatory requirements.
• Keep up to date with the specific requirements for the different clinical evaluation types of documents such as CER, CEP, SSCP, PSUR etc.
• Participate in product development projects and preparation of project deliverables, including conducting literature searches, procuring clinical evidence, and giving input to risk evaluation as well as clinical and regulatory strategies.
• Interact, collaborate, and provide regulatory advice to staff both internal and external to the Cook organization, including those of marketing partners and third-party distributors.
• Work closely with product engineering, Medical Education and Clinical Research, and domestic regulatory teams to ensure consistent regulatory communications.
• Serve as the expert on one or more sub-function topics within regulatory affairs.
• Remain current and apply the understanding of international regulations and standards, as well as Quality System requirements in carrying out duties.
• Offer ideas on the department’s strategic planning and organizing of international projects.
• Perform data entry duties in various computer databases.
• Mail, fax, scanning copy, and file documents related to regulatory submissions.
• Participate in Cook working groups as requested by CBI management.
• Assist Management with other corporate duties when required.

Qualifications

• Bachelor's degree in Science or Engineering.
• Master's degree in Science, Engineering or Regulatory Affairs is preferred.
• A current Regulatory Affairs Certification or two (2) years of science, quality or international regulatory experience is preferred.
• Scientific and technical writing; making persuasive arguments in a cross-cultural setting.
• Excellent written, verbal and listening skills.
• Proficiency in a second language is preferred.
• Bachelor's degree in Science or Engineering.Master's degree in Science, Engineering or Regulatory Affairs is preferred.
• A current Regulatory Affairs Certification or two (2) years of science, quality or international regulatory experience is preferred.
• Scientific and technical writing; making persuasive arguments in a cross-cultural setting.
• Excellent written, verbal and listening skills.
• Proficiency in a second language is preferred.

Physical Requirements:

• Must be able to perform the essential functions of the job, with or without reasonable accommodations
• Limited exposure to hazardous chemicals used in the manufacture of the product.
• Physical demands are typical of an office and classroom environment.