Regulatory Affairs & Quality Assurance Manager – Based in Belgium
- Mechelen, Belgium
This position will lead and manage all Regulatory and Quality activities at the affiliate, ensuring compliance with Alcon global/local procedures, national and international regulations/ standards/guidelines for management of Alcon marketed products (drugs and devices).
We are seeking someone experienced working within an international environment, who can demonstrate strong Regulatory experience, ideally with some Quality, as well as being a functional leader and team player.
In addition, we are seeking those who can function as a responsible Pharmacist.
You will be fluent in English, both oral and written and have a good level of Dutch.
• Promote a strong Quality Culture and awareness of regulatory and customer requirements. Drive awareness of the Quality System as a strategic platform for the commercial business.
• Engage and motivate QA and RA personnel through adequate training and effective communication, providing feedback to direct reports through one to one discussions, performance reviews, recognition and coaching.
• Perform the duties as Quality Management Representative in accordance with ISO requirements as required.
• Responsible for regulatory plans, submission, and approval of clinical trial and marketing authorization applications for all new products and life cycle management of marketed products in the Country, aligned with Global Regulatory and Region and Country business strategies and plans
• Responsible for maintaining records of regulatory submissions and communications with the relevant regulatory agencies.
• Monitor and provide regulatory intelligence on new medical device legislation, guidance and policy proposals impacting Alcon's products or processes. Provide regulatory intelligence on competitive products and companies.
• Accountable for ensuring Alcon is adequately represented in relevant regulatory advocacy groups, to ensure the company position is considered as new regulations are proposed by health authorities
• Develop and maintain excellent working relationships with health authorities; identify regulatory risks for investigational and marketed products and develop strategies to minimize those risks.
• Ensure timely regulatory impact assessment for products and plan RA submissions according to assessments.
• Manage local labelling, advertisement and promotional materials review and approval in compliance with Global and local regulatory requirements.
• Ensure adequate Health authority communications when required, by liaising with Global RA, Medical Safety and other functions as appropriate
• Ensure that processes and procedures needed for an effective Quality System are established, implemented and maintained, including but not limited to, self inspections, supplier qualifications, CAPA process and SOP compliance.
• Promote process improvements through the use of the internal audit program, CAPA/deviations system and feedback process (complaints)
• Gather, maintain and report key quality indicators in accordance with division requirements and ensure visibility with the Commercial leadership team.
• Lead audit preparation activities, facilitate, manage and close out external audits by Health Authorities and Notified bodies, ensuring all corporate requirements are met and robust CAPAs implemented.
• Ensure that products are received, stored, handled, distributed and transported according to regulatory requirements and that all GxP suppliers are adequately qualified and monitored.
• Ensure continual Quality System Compliance by adherence to established and evolving Alcon and regulatory requirements.
- Extensive experience in Regulatory Affairs/Regulatory Compliance
- Proven experience leading people and organization
- Qualified Pharmacist
- A track record of successful execution of regulatory submissions and approvals for medical devices.
- High energy, collaborative and experience initiating and leading change.
- Ability to influence senior stakeholders in a global environment
- Effective communicator and ability to work with a variety of departments and regulatory bodies.
- Knowledge of appropriate regulations and standards
- Fluent in both spoken and written English is a requirement
- Good level of Dutch
Nice to have
- Quality Assurance
- Fluent in French helpful
Computer literacy with standard software platforms
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