Senior Regulatory Affairs and Quality Specialist
Job No: 616015
Department: CLTD - Regulatory
Work type: Permanent
Location: Mumbai (Bombay)
Recruitment Contact: Madhura Ahire
Accountabilities:
Accountability 1: Regulatory Champion/Representative
- Provide critical regulatory timelines to support accurate planning, forecasting and budgeting for the SA Markets
- Champion and represent SA when liaising and collaborating with Global and Asia Pacific (APAC) counterparts for Regulatory Affairs requirements as part of the Cochlear Product Innovation Process.
- Lead a culture of business (code of conduct)/regulatory (local legislation) compliance in SA and provide guidance and support to the Cochlear team and distributor team members to ensure compliance
Accountability 2: Regulatory Product Registrations
- Implement product registration plans and communicate status to relevant stakeholders to deliver timely product submissions and approvals
- Participate in the APAC New Product Introduction (NPI) process to ensure that all regulatory requirements are communicated between SA and APAC and satisfied for timely product launch
- Establish and maintain regulatory files and licenses in a format consistent with legislative requirements and business requirements
- Build and maintain relationships with relevant industry associates, regional regulatory authorities across the SA region and Cochlear global teams
- Facilitate communication with applicable regulatory agencies and authorities during ongoing review of submissions.
- Follow up all submissions and post-approval commitments and renewal activities in a timely manner
Accountability 3: Quality Management System
- As the Quality representative for SA, fulfil all requirements related to the quality function in partnership with the Global and APAC Regional teams
- Establish and maintain a Quality Management System that supports operational excellence and achieves Good Importation Practice (GIP) and Good Distribution Practice (GDP) certification across SA markets, as required
- Manage quality related issues and mandatory reporting to auditors
- Oversee local inspection activities for products and the inventory database for quality requirements
Accountability 4: Surveillance and Compliance
- Review sales and marketing literature and product labelling for approved product claims and regulatory compliance
- Partner with the SA Marketing team to develop marketing collateral and procedures that are complaint with regulatory standards
- Participate in Cochlear’s post market surveillance system and ensure that it is compliant with SA’s regulatory requirements
Team Role (Individual contributor):
- Follow relevant quality procedures in order to deliver quality products and services and identify and support the implementation of continuous improvement. Undertake additional quality responsibilities (e.g. audit) when appropriately trained to undertake these responsibilities.
- Contribute ideas on systems and process methods to improve deliverables.
- Work safely, complying with all safety procedures, rules and instructions; and reporting workplace hazards, incidents or injuries to manager.
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