Director & Head of Quality & Regulatory Country Hub
vor 1 Monat
Establish, implement and lead regulatory and quality strategies to actively support Fresenius Medical Care's Business in adequate time and way. Ensure product safety, quality and regulatory compliance in accordance with applicable laws and standards in all countries in scope of the hub.
**Your assignments**:
- Establish QR structures, national teams to fulfill regulatory and business requirements; build, lead and continuously develop team, including hub budget responsibility and control adjusted to finance policies and guidelines
- Responsible for all regulatory affairs and quality tasks in the hub incl. management of product complaints and product regulatory conformity, safety, and post market systems in all countries of Hub as well as communication to applicable SysQaRa functions in accordance with corporate SOPs
- Provide leadership and oversight for the strategic and technical regulatory direction for the registration for all FME MedTech products relevant in the Hub (incl. medical devices, medicinal products, combination products, software as MD, etc.)
- Monitor, evaluate and inform key internal stakeholders about applicable national and hub regulatory requirements; coordinate internal implementation and actively contribute to the development of new regulatory requirements. Responsible for the fulfillment and compliance with all the hub regulatory requirements w/r to customer and suppliers
- Monitor regulatory compliance of distributors and critical suppliers
- Lead negotiations with key health authority agencies during development, registration, and product lifecycle activities to resolve regulatory issues and/or negotiate approvals; establish and maintain proactive and professional communication & relationship with agencies
- Support and accelerate market access for our products in line with regulatory requirements, verticals and commercial operations roadmap and establish an active prioritization mechanism based on resource management
- Fulfill all duties associated to the corporate MAH for medical products and local MAH and associated product responsibilities, local and hub key contact for authorities. including performing pharmacovigilance reporting as well as reporting and execution of safety actions in accordance with corporate SOPs and local regulations
- Report customer complaints, incidents and any potential safety issues in compliance with corporate SOPs and execute medical device incident/adverse event reporting in compliance with local country regulations.
- Implement and maintain an effective and compliant Integrated Management System covering Product Quality Management system as well as other applicable management system requirements in accordance with corporate strategy
**Your profile**:
- Degree in Pharmacy, Chemical, Bioengineering, Health Professional. Desirable master’s degree in quality, regulatory, business or related to the activity 2-3 years professional experience in similar position
- Comprehensive leadership experience (min. 5 years) in the healthcare industry with familiarity of leading diverse teams in the same or similar position
- Thereof minimum of 5 years in Regulatory Affairs, ideally for medical devices and medicinal products, or Quality function
- Comprehensive expertise and knowledge of RA and applicable regulatory requirements in the Hub region
- Extensive experience in leading negotiations with health authorities incl. experience with drug & medical device registrations
- Knowledge in applicable norms as: local laws of the countries. Knowledge of ISO 9001, GMP-Good Manufacturing Practice, GDP, GVP and GSP. Desirable Knowledge in ISO 14000, ISO 31000, ISO 13485, ISO 9001
- ‘Problem solver’ with demonstrated ability to provide strategic direction at an advanced level; highly structured and systematic while acting independently with a solution-oriented mindset
- Integrative nature and proven track record of building high performing teams (incl. knowledge in organizational development and change management); ability to lead virtually
- Strong professional attitude characterized by a result, quality, patient and solution oriented working style
- Good record keeping skills - Presentation skill, ability to set priorities and take decisions
- Plans and Aligns: Plans and prioritizes work to meet commitments aligned with organizational goals.
- Manages Complexity: Makes sense of complex, high quantity, and sometimes contradictory information to effectively solve problems.
- Strategic Mindset: Sees ahead to future possibilities and translates them into breakthrough strategies
- Balances Stakeholders: Anticipates and balances the needs of multiple stakeholders
- Cultivates Innovation: Creates new and better ways for the organization to be successful
- Situational Adaptability: Adapts approach and demeanor in real time to match the shifting demands of different situations
- Develops Talent: Develops people to meet both their career goals and the organization's goals
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