Sr. Regulatory Affairs Associate

Covidien

Nellcor Puritan Bennett is now the Respiratory and Monitoring Solutions business unit of Covidien and is relocating its operations to Boulder, CO. Our systems are used to monitor, diagnose and treat respiratory disease and sleep disorders, and they provide life sustaining ventilation and oxygen support for patients.

In addition, to Respiratory and Monitoring Solutions, Covidien also manufacturers, distributes and services a diverse range of industry-leading product lines, including surgical devices, energy-based devices, pharmaceutical products, imaging solutions, patient care and safety products, and medical supplies.

For more information, visit us as www.covidien.com. Respiratory and Monitoring Solutions' jobs are listed as Nellcor/Puritan Bennett.

Summary

Ensures compliance to FDA and other applicable regulations. Prepares, analyzes, and submits dossiers to various governing agencies in supporting business growths. Supports applicable regulations including ISO, local, state, and/or federal requirements.

Essential Duties & Responsibilities:

Monitor and provide management with impact of changes in the Regulatory environment.

Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management.

Document, consolidate and maintain oral and written communication with FDA, notified bodies, and clinical investigators.

File annual notification, annual establishment, state, federal registrations, product changes of FDA, Health Canada, EU, notified bodies, and other regulatory agencies throughout the world.

Support Design Control process.

Provide Regulatory perspective and requirements in cross-functional project teams.

Execute and manage submissions such as US FDA Section 510(k) Notifications, Pre-market Approval (PMA) Applications and Supplements, EU IVDD Technical Documentation, and global product registrations.

Participate and conduct Internal Audits.

Participate in third party audits of the Quality Management System and assist in the development of responses to support audit corrections and rebuttals.

Review change control documents and ascertain Regulatory impact for external and internal documents.

Coordinate the notarization and legalization of regulatory documents.

Maintain external references and lists of national and international regulations, standards and FDA guidance documents that affect the products and operations.

Assist in development/maintenance of regulatory files, records and reporting systems of systematic retrieval of information.

Qualifications:

5-8 years of RA experience

B.S. or B.A. degree required.

Must have knowledge of U.S. and/or European/International regulations and standards Experience in preparing regulatory submissions Experience interacting with FDA and/or other regulatory agencies Must work well in team environments.

Must demonstrate leadership skills in team setting.

Proven analytical abilities

Solid understanding of manufacturing and change control, and an awareness of regulatory trends

EEO/AA