RAQA Southern Europe Head

This role also oversees the maintenance of product quality and compliance as well as management of the Quality Management System processes associated with Regulatory Quality and post market and ensures that each of our customers experiences live up to our brand Southern Europe Head provides strategic leadership and coordination of these key functions to ensure that the short-term and long-term objectives of the company are met. As such he/she is partnering with the business other functions as Operations the Governing Agencies the Regulatory & Certification Authorities and Trade position will assure that all needed licenses are available for importing and Distributing MD Biocides and Cosmetics; as far as Xray products and HT invoicing.

What you will do:

• Drive the quality first policy of exceeding the quality expectations of our customer and regulatory authorities
• Provide a strategic direction and tactical focus to the Quality and Regulatory Affairs organization and influence the direction of divisional RAQA activities
• Act as the Southern Europe RAQA Leader reporting performance risks and issues to Southern Europe Leadership team and to the European RAQA Leader
• Lead and direct meetings required to drive closure of regulatory PMS and quality issues
• Acts as a subject matter expert to the South Europe organization
• Identify implement manage and provide updates for regulatory PMS and quality metrics across the European Region
• Implement appropriate enhancements to drive process improvements to ensure adherence to regulatory and quality practices and the achievement of metrics for the Southern Europe RAQA organization
• Provide strategic direction to RAQA integration activities of new acquisitions ensuring RAQA systems integration within the Southern Europe and define integration strategy for RAQA in the area
• Lead Third Party Competent Authority or Notified Body audits within the local organization. Represent regulatory PMS and quality processes during internal and external audits
• Define targets KPIs performance objectives etc. in line with regional objectives for individuals within functional role and manage direct reports to meet or exceed these targets
• Recruit select and on-board top talent
• Develop talent within team to increase performance
• Actively address performance issues on team
• Maintain a high level of team engagement
• Ensure that QMS is conducted in compliance with Iso requirements regional SOPs and guidelines Quality Policy Southern Europe requirements government regulations in support of company mission
• Identify interpret and implement regulatory system changes to support evolving regulations and international standards
• Ensure that pre-market submissions product registrations quality and compliance practices are conducted in compliance with EU requirements and guidelines; MDR Southern Europe requirements and government regulations in support of company mission; assuring needed Support to the southern Europe business
• Be the main point of contact for Local Competent Authority and Trade Association
• Participate in advocacy activities of a more advanced strategic nature
• Liaise with local Competent Authorities and local Trade Associations and ensure that new local Regulatory requirements are regularly reported to Stryker EMEA Regulatory management and local responsibility involves active participation to meetings / conference with these organizations to lobby and protect the Stryker business in Southern Europe region
• Ensure that PMs conducted in compliance with regional requirements and government regulations in support of company mission
• Be partner of the Southern Europe business considering the business needs and informing about the RAQA issues that could impact the normal business activities
• Be Partner of Southern Europe Functions Including and not limited to Operations department assuring that all the local and regional requirements are fulfilled
• For countries with this figure be the Technical Manager in front of the CA assuming the legal responsibilities defined by local CA

Environmental

• Where appropriate ensure that the Environmental Management System is implemented and maintained in accordance with the ISO and Legal requirements and the Stryker EU QA guidelines and procedures
• Where appropriate organize at fixed intervals formal Management reviews of the Environmental System to ensure and monitor its suitability adequacy and effectiveness
• Where appropriate report to management on the performance of the Environmental Management System including needs for improvement
• Carry out the environmental reports in the country as required by local regulation
• Be the main contact person in the country for environmental and have needed legal powers to act in the name of the local entity

What you need:

Required:

• Bachelors degree in engineering or another relevant related field
• Minimum of 12 years experience 8 years of supervisory experience
• Fluency in English Spanish and or Italian

Preferred:

• Knowledge of Portuguese language
• Masters Degree or equivalent
• Regulatory Affairs certification: certification given by RAPS (Regulatory Affairs Proffesionals Society)
• Qualification / Certification in QMS for ISO 9001 13.485

Competencies

• Demonstrated knowledge and application of regulatory requirements including ISO FDA and international requirements including Spanish Portuguese and Italian requirements
• Demonstrated experience as a transformacional leader that inspires and motivates the team while coaching them assuring active contribution to create a high performance work team
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• Demonstrated expertise in regulatory systems in a regulated environment
• Demonstrated verbal written and interpersonal communication skills
• Demonstrated ability to work in a team environment interact effectively with management from other functions
• Demonstrated ability to manage a multi-discipline multi-technology team-based organization and assume responsibility of quality regulatory and compliance targets
• Demonstrated ability to initiate work
• Demonstrated analytical ability
• Demonstrated ability to make effective decisions
• Experience with recruiting people development
• Ability to influence across the organization
• Project management and time management skills writing coordination and execution of more complex RA / QA / PMS items
• High attention to detail and process consciousness
• Strong IT skills including Microsoft Office

What we offer:

• Flat hierarchies and responsibility.Through flat hierarchies we strengthen the initiative and willingness of our employees to take over responsible tasks.
• We grow talent.At Stryker we offer great personal and internal career development for our employees with the possibility to make both vertical and lateral position movement.
• Team spirit & engagement.We create engaged and inclusive teams that encourage colleagues to share their diverse perspectives and opinions.
• Competitive salary and Benefits.With us you will receive a competitive salary and benefits commensurate with your job.
• Recognition of your performance.At our company outstanding individual and cross-functional team performance is rewarded. Ideas projects or other exceptional achievements can be submitted for various awards on a local and global level.
• Stryker Womens Network (SWN).The SWN is committed to an open and modern corporate culture that fosters the development of talented and dedicated women. SWN is open to all employees and strongly advocates an inclusive work environment.

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