Senior Regulatory Compliance Specialist

Summary:

12 Month Contract

The Regulatory Compliance Specialist is responsible for establishing and maintaining a robust Compliance Program for the manufacturing sites under their scope of responsibilities, in order to ensure compliance to local, national and international regulatory standards, company policies, procedures and corporate requirements.

Responsibilities

• The Regulatory Compliance Specialist will be a member of the Site Quality Operations Team and will work closely with site.
• Establish and maintain robust compliance program ensuring compliance to local, national and international regulatory standards, company policies and procedures, and Corporate requirements.
• Establish and maintain regulatory inspection readiness plan at manufacturing site within the scope of responsibilities, in preparation for any regulatory inspection (internal and external).
• Partnership with the site on the formulation of robust responses to regulatory agencies in order to address manufacturing related observations. Collaborate with other business partners in the identification and implementation of corrective actions. Ensure effective and timely completion of all corrective actions.
• Establish and maintain programs that ensure the verification and monitoring of the effectiveness of the Franchise quality system and its compliance to applicable regulations and standards.
• Ensure results of monitoring process are routinely communicated to management through Site Management Review process.
• Assure all external auditing companies meet internal requirements prior to executing any portions of the contracting agreement.

Requirements:

• A minimum of a Bachelors degree is required in science, engineering, or equivalent is strongly preferred. Post Graduate Qualification in Quality / Regulatory preferred.
• A minimum of 5 years of relevant experience in the Quality and Regulatory Compliance in the medical device/ pharmaceutical industry.
• Prior experience managing External Regulatory and/or Notified Body Inspections (e.g. FDA, BSi etc) is preferred.
• Experience in auditing to FDA QSR, MDSAP and ISO 9001/ISO 13485 standards, additionally a working knowledge of other related medical device national regulatory standards
• Compliance experience and reputation, large-scale QMS experience.

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