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International Regulatory Affairs Manager - Santa Maria, CA

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Marketing, Support

Projektbeschreibung

Objective

Under general direction, will prepare regulatory submission documents for FDA and International filings and provide regulatory assessment of manufacturing changes and marketing promotional materials.

* Secure and maintain establishment annual licenses, registrations and listings. Drive International Product Registration projects to completion. Negotiate and interact with international regulatory authorities during the development and review process to ensure submission approval.
* Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities.
* Review and approve domestic and international product labeling, promotional materials, product packaging, and advertising copy. Conduct regulatory assessments for changes to marketed products.
* Prepare regulatory submissions including 510(k) submissions; assist in the preparation of IDE and PMA.
* Provide review of general internal Quality System compliance to regulations.
* Ensure compliance with product post-marketing approval requirements.
* Submit Product Complaints System reporting including FDA MDR's, EU Vigilance, and Canadian Medical Device reporting.
* Provide cross functional or new product development teams with guidance to meet regulatory requirements and to support product filings.
* Assist QA in maintenance of CE Technical Files.
* Maintain Declarations of Conformity.
* Review proposed document changes to determine level of impact and consequent submission requirements (including Notified Body Notices Of Change). Provide regulatory input for and appropriate follow-up to inspections and audits, and accompany inspection team(s) as required.
* Assist in the development of departmental policy and regulatory strategy.
* Develop and maintain productive and effective relationships with regulatory authority reviewers, peers, and superiors.
* Demonstrate a high standard of work ethics and professionalism to regulatory authority reviewers, peers, and superiors at all times.
* Represent the company in a positive and supportive manner at all times.

Required Skills

* Knowledge of FDA QSR's and U.S. Food, Drug, and Cosmetic Act as amended.
* Knowledge of ISO 13485, Medical Device Directives and Health Canada (CMDR) requirements,
* Knowledge of medical device manufacturing or a related field.
* Skill in demonstrating a professional phone manner.
* Ability to work independently, take initiative and make decisions within department/company guidelines.

Required Experience

Bachelor's degree (B.A./B.S.) from four-year college or university in a scientific field; and three to five years related experience; or equivalent combination of education and experience. Previous medical device regulatory experience desirable.
To find out more about Real please visit www.realstaffing.com

Projektdetails

  • Einsatzort:

    Santa Maria, California, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Permanent

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland