Quality and Regulatory Expert
A top-tier medical device company is seeking a seasoned Quality and Regulatory Manager to spearhead its quality assurance initiatives and ensure regulatory compliance in key markets.
Key Responsibilities:
* To lead the company-wide quality assurance agenda, guaranteeing that customer requirements for products and services are met, along with regulatory compliance in target markets.
* Ensure the effective functioning of continuous quality improvement based on performance measurement.
* Manage all areas of risk management related to design control in accordance with ISO14971.
* Responsible for regulatory clearance and maintenance for the Company's products in target markets.
* Management of the QA team.
* Proactive management of processes to ensure product and service quality.
* Act as Management Representative for the Quality Management System.
* Manage the maintenance of the Quality System to ISO13485 and FDA requirements.
* Represent the quality department in all NPI/NPD activities to ensure new products are compliant to international quality and regulatory requirements.
* Complaints handling for medical reporting and filing to competent authorities.
* Regularly review and manage change control process.
* Ensure products are cleared to appropriate markets as per Regulatory plan.
* Manage Regulatory Affairs support to internal and external customers.
* Ensure company is informed of changing regulatory and compliance requirements.
Requirements:
* University Degree or Post Graduate qualification, preferably in Quality Assurance.
* 8+ years of experience in Medical Devices or regulated industry.
* Significant regulatory affairs experience including international regulatory processes.
* In-depth knowledge of maintaining a certified Quality Management System.
* Knowledge and application of Quality tools and Methodologies.
* Previous experience of impact of regulatory control on commercial products.
* Trained QMS Internal Auditor.
* Awareness of quality assurance processes.
* High level of attention to detail.
* Proven leadership skills.
* Excellent verbal and written communication skills.
* Results-orientated and self-starter with ability to work on own initiative.
* Knowledge of and commitment to continuous improvement and problem-solving.