LSC have a great contract opportunity for a Senior Regulatory Compliance Specialist to join a multinational medical device company based in Cork.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- The Regulatory Compliance Specialist is responsible for establishing and maintaining a robust Compliance Program for the manufacturing sites under their scope of responsibilities, to ensure compliance to local, national and international regulatory standards, company policies, procedures and corporate requirements.
- The role may interact with teams across the region at several Sites to achieve a compliance framework that focuses on oversight and execution in a systematic way to enable proactive compliance success in delivering business needs across operating units.
- Provide leadership, oversight, and strategic guidance for Regulatory Compliance issue for the team and site the Regulatory Compliance Specialist is responsible for.
- Be the POC and provide leadership / oversight of inspection readiness, audit management, and responses for internal and external inspection.
- This individual is also responsible to conduct internal audits.
- The Regulatory Compliance Specialist will be a member of the Site Quality Operations Team and will work closely with site.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 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.
- Strong knowledge of quality and compliance in a regulated manufacturing environment (GMPs).
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Grainne Hodnett at +353 21 4777 329 if you have any more questions about this opportunity!