Quality Assurance Regulatory Affairs Manager
2 weeks ago
About Septodont
Septodont is a leading manufacturer of dental materials and equipment.
The company values innovation, quality, and customer satisfaction.
Job Summary
We are seeking an experienced Quality Assurance Regulatory Affairs Manager to join our team in Taloja MIDC, Navi-Mumbai, Maharashtra.
The successful candidate will be responsible for ensuring that our products comply with all regulatory standards and quality systems are maintained and improved.
About the Role
This role involves overseeing quality assurance processes, managing regulatory submissions, and ensuring compliance with applicable regulations and standards.
You will work closely with cross-functional teams, including product development, manufacturing, and marketing, to support the lifecycle of our products from development through commercialization.
Key Responsibilities
- Oversee Quality Management System (QMS), policies and standards to support proper and smooth execution of Quality related activities in meeting the specified standards and requirements, consistent with GMP.
- Ensure risk management principles are implementing through the organization in all activities.
- Establish company quality plan including quality policy (based on corporate QA policies and procedures) and continually improve it.
- Ensure deviations/non-conforming products management and implement preventive measures and corrective actions. Evaluate and ensure CAPA effectiveness.
- Ensure Quality Management System complies as per Drugs and Cosmetics Act, Medical Device Rule 2017, MDD & Medical Device Regulations and is effectively established, maintained and efficient.
- Ensure suppliers and customers qualification, maintain their approved status according to applicable procedures.
- Manage change controls and authorize their implementation after assessment and approval from authorities/notified body/legal manufacturer.
- Oversee internal audits as well as vendor/supplier/customer audits as per GMP & ISO 13485 & ISO22716 & MDR requirements.
- Prepare and implement the project inspection strategy to cover all project phases from the QA/RA perspective.
- Facilitate and manage inspection or audit from customer, notified body and regulatory authorities and their follow up actions.
- Continuously review quality control processes, procedures, and capabilities in order to sustain the most cost-effective and efficient methods for meeting quality requirements and making recommendations for improvement as appropriate.
- Manage and control all quality control activities in accordance with identified Quality Assurance standards, company procedures, client specifications and contract requirements.
- Assist in the production of generic and project-specific method statements and risk assessments.
- Handle all product complaints and taking proper corrective measure under root cause analysis.
- Provide training to all employees related to ISO, MDR, GMP and Medical device regulations as per EU.
- Ensure all regulatory compliances related to products and processes are met.
- Ensure regulatory watch and quality standard watch applicable to QMS and QC test.
- Ensure process validation, cleaning validation, equipment and utilities qualification and monitoring, revalidation program and calibration.
- Ensure batch record review and approve batch disposition.
- Handle in Process QA activities of manufacturing and packaging areas.
- Conduct and document management review, follow and communicate KPIs as defined.
- Approve and coordinate any returned products and disposal of returned products.
Requirements
To succeed in this role, you will need:
- A minimum bachelor's degree in science or related field (BioMedical, Biochemistry, Pharmaceutical Science, Biotechnology etc.), or experience demonstrating equivalent required knowledge and competencies.
- Certification in a regulatory or quality discipline would be an asset (IGMPI).
- 5+ years in a quality assurance management role in Medical Device and leadership equivalent role;
- Effective communication and report writing skills;
- Good negotiating skills with customer-oriented attitude;
- Excellent analytical abilities to grasp the key points from complicated details;
- Good leadership qualities to lead projects to successful completion;
- Basic knowledge of applicable software to infer statistical data;
- Familiarity with the tools, concepts and methodologies of quality management;
- Knowledge of and experience with all regulatory requirements concerning class I, II and III devices including
- Knowledge of QSR/QMS to support ISO-13485, ISO22716, GMP, Medical Device Regulation (2017/745), compliance/processes, CE Marks and audits;
- Experience with lab work;
- Familiarity with manufacturing techniques, project management and formal continuous process improvement techniques (Lean Management).
This role offers a competitive salary of ₹25 lakhs to ₹30 lakhs per annum, depending on experience.
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