Senior Regulatory Affairs Specialist

Date Posted:

11/23/2009

 

Job ID:

1695

 

Company:

We are a large global healthcare products company. We design ground-breaking medical solutions for improved patient results and bring worth through clinical leadership and excellence. We have employees in almost every country with an increasing presence in emerging markets around the world. Our goal is to augment growth by increasing research and development initiatives and by enhancing our international infrastructure.

 

Location:

Southern CA

 

Reports To:

VP Regulatory

 

Salary:

65K - 80K

 

Education:

B.S. or B.A. degree required. MS or MBA preferred

 

Requirements:

Medical device focus and 510(k) experience. 6-8 years of RA experience Preferred Skills/Qualifications: 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 Skills/Competencies: Must work well in team environments; Must demonstrate leadership skills in team setting. Other Skills: Proven analytical abilities; Solid understanding of manufacturing and change control, and an awareness of regulatory trends.

 

Duties:

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 FUNCTIONS: 1. Review clinical protocols to be used in submissions. 2. Prepare, review and file appropriate FDA per market submission to ensure devices are commercially available in the U.S.: preIDEs, IDEs, 510(k)s, PMAs and PMA Supplements. 3. Represent RA as core team member to drive innovation on Tech. Dev. Projects and follow through to market release. 4. Develop Regulatory Strategies for new or modified products and prepare project plans & budgets. 5. Monitor and provide management with impact of changes in the Regulatory environment. 6. Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management. 7. Document, consolidate and maintain oral and written communication with FDA, notified bodies, and clinical investigators. 8. Support Design Control process. 9. Prepare Rational to file documentation for modifications to devices when appropriate. 10. Participate in FDA & other notified body Inspections. 11. Author and/or review regulatory procedures and update as necessary. 12. Review change control documents and ascertain Regulatory impact for external and internal documents. 13. Assist in development/maintenance of regulatory files, records and reporting systems of systematic retrieval of information. 14. Review promotional material and labeling for regulatory compliance.