Job Description
required to lead and coach the Regulatory compliance team, while managing company product development systems and associated project teams, promoting and effecting compliance to; quality, business and health & safety systems and market/legal regulations.
The successful candidate will formulate quality strategy through the product development process - regulatory compliance, risk management, design control and quality systems - ensuring Product Development meets all applicable regulatory requirements.
This is a permanent role with a blue-chip healthcare manufacturer based in Galway
Responsibilities of Regulatory Compliance Lead:
Co-ordination of team activities in line with departmental objectives and project goals.
Supervision and development of staff reporting to them in line with departmental and project goals.
Provides regulatory compliance, risk management, design control and quality systems expertise to the team.
Liaise with corporate and divisional quality systems and regulatory affairs personnel in ensuring compliance of product development activities to internal and external requirements.
Analysing, reducing and managing risks associated with New Products through their lifecycle.
Liaise with R&D, Regulatory Affairs, Clinical, Marketing, Process Development and Manufacturing functions in a project team environment.
Monitor the release and updates of quality policies to ensure compliance with Product Development needs and communication of this information to the Product Development Group.
Continually seeks to drive improvements in product and process quality.
Implement, maintain and update procedures that ensure that R&D documentation meets the company?s Product Development Process and Control requirements.
Provides the quality/independent review at defined reviews, project plans, risk management, validation protocols and reports, for new development projects as well as process changes to existing products.
Requirements for Regulatory Compliance Lead:
Bachelors Degree in Science, Engineering or equivalent technical discipline.
5+ years? experience in regulatory compliance or quality assurance role involving New Product Development and New Product Introductions.
People management and project management experience.
Proven experience with Risk Management and Continuous Improvements.
Strong Validation experience, particularly with Process Validation regarding NPIs.
Proven Quality Systems knowledge and experience to FDA regulatory guidelines.
Please contact Larry on +353 1 2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
Key words; Regulatory Compliance, Regulatory Affairs, New Product Development, R&D, New Product Introduction, Process Development, Quality Systems, Commercial Launch, Medical Devices, Pharmaceutical, Galway, Clare, Connaught.