Work Flexibility: Hybrid
RAQA Southern Europe Head
The hired candidate for this position can located in Madrid or Rome. Hybrid working model is possible, however, a minimum weekly requirement of onsite visits to the local Stryker facilities is mandatory. Travelling is estimated t o 20%
Reporting to the Europe Director, this position provides leadership to the RAQA Southern Europe team to ensure achievement of business goals and objectives by ensuring market access (impotantion, distribution, and maintenance) of products compliant with all applicable local, agencies and regulatory bodies (Medical Devices, Cosmetics, Biocides, non-MD, Human Tissue). The RAQA Senior Manager Southern Europe is accountable for ensuring cross functional alignment and support to meet regulatory and quality compliance requirements. They direct and contribute to initiatives within the organization, with groups engaged in the development of good regulatory practice and a quality culture. This position has the overall responsibility to develop, facilitate and execute comprehensive regulatory strategies through all phases of market product lifecycle, to accelerate and ensure successful product registrations for both product launches and change management for marketed products.
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 promise.RAQA 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 Associations.This 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 management.This 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 :
* Bachelor's 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
* Master's 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
* let
* 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 Women's 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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Travel Percentage: 20% #J-18808-Ljbffr