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Food & Drug Administration Attorney / Health Care Attorney in Irvine, CA

Halyard Health Jun 12,2017 Apr 26,2017 Location Irvine CA
This job is expired...

In-House

Attorney

Health Care

Litigation - Regulatory Enforcement (SEC, Telecom, Energy, etc.)

5-10 yrs required

Profile

Associate Director, Regulatory Affairs - West Reporting to the Global Director of Regulatory Affairs, the candidate will provide global regulatory knowledge and oversees the resources to assure timely marketing registration of device products along with registration maintenance in compliance with all applicable regulations. Specific expectations include: Leadership in Regulatory Affairs and Compliance; Regulatory representative during FDA, Notified Body, and external agency inspections; Impactful communications with regulatory agencies; Problem solving and resolution as well as complaint and product failure investigations. Monitor and trend staff performance. Provide leadership and direction in the implementation of regulatory policies, procedures, and strategies that assure domestic and global regulatory compliance. Will be responsible for the Regulatory Affairs operations for the Acute Pain franchise to ensure that business objectives are achieved and comply with applicable regional/country regulations. Manage a Regulatory Affairs staff focused on the development and commercialization of new device products and support of current products. Incumbent will act as the Regulatory Representative for the assigned business unit and will represent the Corporation in interactions with regulatory agencies, customers and purchasing organizations, outside companies, and relevant professional organizations. Manage regulatory staff of up to 5 direct reports. Assure resources are aligned to support the regulatory requirements of multiple key medical device businesses and establishments. Coordinate the timing, preparation, and submission of domestic and international regulatory filings. Provide leadership to ensure that Regulatory Affairs attracts, develops, and retains the best people and fosters an environment that motivates a diverse team to fully use its capabilities in achieving desired business results. Provide scientific and regulatory consulting services to regions, business units, and new product development teams and liaise with key healthcare and regulatory experts. Serve as consultant and advisor to management and project teams on compliance with applicable regulations. Monitor changes to domestic (federal & state) and international regulations that may impact the businesses and oversee strategies to manage required change. Collaborate with Medical Sciences, Clinical Research, Product Safety, Product Development, and Quality Assurance staff to ensure development of safe and efficacious products. Ensure that all matters within the incumbent's area of responsibility which could adversely impact the business of the Corporation are communicated in a timely manner. A four-year technical degree and a minimum of 5-10 years or equivalent of relevant regulatory experience; in-depth knowledge of applicable regulatory law; knowledge of quality and business processes, and excellent communication skills required. An advanced degree (MS, MBA, PhD, JD, MD), ambulatory infusion systems, and/or regulatory affairs certification is highly preferred. Experience should include in-depth knowledge of domestic (FDA) and international regulatory requirements and medical device registrations, design control activities for medical devices, as well as direct management of FDA and Notified Body inspections. Strong communications (written and oral), analytical, quantitative and problem solving skills are required.

Additional info

Job ID: 731010

Company info