Director - Regulatory Affairs (IRC1246)Posted: November 19, 2009
Reporting to the Private Label Business Manager with a dotted line to Corporate Regulatory Affairs, this position develops and implements regulatory strategies and guidance based on U.S. and International requirements as defined in FDA regulations, ISO 9001 Standards, ISO 13485:2003 Standard, European Medical Device Directives, Canadian Medical Device Regulations, and other International Regulations. Establishes effective dialogue withU.S.and International regulatory authorities. Establishes effective dialogue with the regulatory affairs personnel of our Private Label partners. Directs the planning and preparation ofU.S.and International regulatory submissions for Integra products based on the distribution strategies of Integra• Ts private label partners. Supports the regulatory affairs departments of our Private Label partners on regulatory submissions and registrations for Integra Private Label products. Facilitates timely product registrations and regulatory approvals. -. Obtains/generates information to be submitted to regulatory authorities and prepares required regulatory submissions. -. Responsible for regulatory functions including planning and filing of documentation with domestic and international regulatory agencies. -. Acts as liaison with appropriate local, national and international regulatory authorities. -. Provides regulatory guidance to clinical affairs, quality systems, manufacturing, and development groups. -. Coordinates with and provides regulatory support to the regulatory affairs departments of Private Label partners on regulatory submissions and registrations for Integra Private Label products. -. Responsible for providing regulatory strategy to private label partners for new product approvals. -. Participates in Due Diligence as requested and approves regulatory provisions of partnership agreements. -. Reviews changes in manufacturing facilities, manufacturing procedures, and analytical methods. -. Leads relevant project planning and review meetings; participates in the final company document review and approvals. -. Identifies and ensures the establishment and monitoring schedules for submission documentation, review of documentation, protocols and reports received; prepares additional written materials as needed. -. Coordinates and prepares 510(k) Premarket Notifications, IDEs, PMAs, INDs, NDAs, Design Dossiers, Technical Files and other International Registrations. -. Prepares responses to FDA letters, supplements, and amendments; participates in FDA inspections and presentations. -. Participates in Private Label partner audits and inspections by international regulatory agencies. -. Writes departmental SOPs and develops and implements training programs for direct reports and other functional groups to assure awareness of all requirements and maintain compliance with all current regulation. -. Participates in the preparation of the department• Ts budget; ensures that the department operates within capital and expense budget guidelines. -. Keeps apprised of new regulations, standards, policies, and guidances issued by relevant regulatory authorities that may impact the company. -. Reads related regulatory publications and trade association documents; presents information about current regulatory actions. -. Reviews product complaints for MDR, Vigilance, Canadian Medical Device reporting requirements and preparation of Health Hazard Evaluations as required. -. Assists with ongoing training in Quality System Regulation, ISO Standards, and other International Regulations. -. Performs all other related duties as directed by supervisor and management.
Please refer to job code integrals-1246 when responding to this ad.
| Category: | Biotech/Pharmaceutical |
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> Regulatory Affairs
| | Location: | Plainsboro, NJ | | County: | Middlesex County | | ZIP Code: | 08536 | | Pay Rate: | Open | | Job Terms: | full time | | Company: | Integra LifeSciences | | Phone: | email only please | | Fax: | email only please |
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