Regulatory Affairs Leader (North) - Rapid Diagnostics Division

1. Summary:

To ensure a “Quality First” culture is established and maintained, with appropriate procedures to deliver compliance, quality products and services.
To provide regulatory expertise, timely registration and reregistration of products and carry out compliance activities as required by the local regulations and by Alere’s policies and procedures.
To advocate Alere’s regulatory objectives with local industry groups and regulators to drive implementation of harmonised and least burdensome regulatory requirements.

2. Core Job Responsibilities:

Technical / Operational
• Implement and maintain appropriate procedures, irrespective of whether a formal quality system is established.
• If a Quality Management System (QMS) is established, implement and maintain.
• Proactively identify and provide direction for compliance with the required standards, codes and regulatory requirements.
• Conduct internal and supplier audits.
• Supervise product recall and advisory notice processes.
• Ensure postmarket vigilance activities are carried out according to requirements of local regulation and Alere.
• Prepare for and provide training in QA and RA processes to other personnel as required.
• Ensure timely registration and reregistration of defined products.
• Ensure process in place for approval (including QA and RA approval) of labels, marketing collateral and literature.
• Ensure the implementation and administration of effective compliant distribution controls
• Prioritise actions to manage any significant quality or regulatory problem with strong liaison with General Manager and Regional Heads of QA and RA.
• Support Alere’s strategic Quality and Regulatory Affairs Goals and objectives.
• Monthly written reports on QA and RA activities to General Manager and Regional Heads of QA and RA.
• Actively stay connected with changes in global and local quality and regulatory standards and requirements that are relevant to Alere and assess and communicate the impacts of proposed changes.
• Participate in industry body regulatory affairs working group to table regulatory challenges and develop and implement strategies to overcome these.
• Monitor developing regulations and participate in regulatory consultations with the input of Regional Head of RA.
• Gather regulatory intelligence that may be relevant to the business and disseminate as appropriate.


Internal Systems and Processes
• Ensure registrations are undertaken applying an approach consistent with the Alere worldwide product registration process
• Implement and administer regulatory inputs for compliant distribution
• Abide by corporate policies and guidelines, including QA/RA guidance

Customers
• Advise, support and train other internal departments in QA and RA related issues.
• Develop and build relationships with regional and global QA and RA groups and other areas of Alere, suppliers and customers.
• Participate in activities with regulatory authorities with a view to enhancing the profile and perception of Alere as an ethical, responsible and compliant corporation.

Financial
• Seek approval for expenses in line with department specific authorisation levels

People Management and Development
• No people management responsibilities
• Responsible and accountable for own work and follow-up meetings with line manager as required.
• Undertake training and development as required.

Conduct
• Ensure regulatory compliance is upheld at all times.
• Ensure all activities carried out by self are in accordance with legislative employment policies and safety requirements and corporate policy.
• Promote a standard of excellence for quality and customer focus at Alere.
• Promote awareness of QA and RA requirements throughout the organisation.
• Uphold the company’s mission, vision and values and support Alere’s Strategic Imperatives
• Ensure conduct is in compliance with Regulatory Affairs Professionals Society (RAPS) Code of Ethics

• BSc or equivalent.
• Training and experience in Regulatory Affairs and Quality Assurance preferably in the medical device or pharmaceutical industry
• A minimum of 2 years experience in an area directly relevant to the position
• Working knowledge of the medical diagnostics industry.
• Effective knowledge of the regulatory environment in which the business operates including the domestic regulations for in vitro diagnostics.
• Understanding of Quality and Quality Management systems (ISO 13485, ISO 9001 & FDA QSR).
• Ability to collaborate with multiple parties and achieve effective outcomes for multiple stakeholders.
• Ability to articulate complex arguments with clarity.
• Seeks solutions when challenges arise.
• Excellent written and oral communication skills in local language and English.
• Strong mission orientation.
• Excellent attention to detail.
• Strong interpersonal skills.
• Highest levels of integrity and diplomacy.
• Capacity to maintain the highest levels of confidentiality internally and externally.

- Healthcare
- Training
- Laptop

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