EndereçoAre you interested in working for a global company where you can work across functions and on awide-varietyof projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !
Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team:
Who we want:
- Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
- Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management, and leadership teams.
- Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
- Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
- Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.
What you will do:
Compliance
•Must conduct all businesses and affairs in compliance with the laws and the regulations, including with the Foreign Corrupt Practices Act (FCPA) and the Stryker Code of Conduct, in compliance with the highest ethical values.
Regulatory Affairs
•Assesses links between global, societal, and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy.
•Develops and updates global, regional, and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies.
•Provides guidance to integrate regulatory considerations into global product entry and exit strategy.
•Identifies regulatory pathways for initial product designs and provides input to internal stakeholders.
•Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes.
•Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles.
•Critically assesses the impact of changing regulations on pre-approval and post-approval strategies and approaches based on changing regulations.
•Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy).
•Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures.
•Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
•Provides strategic input and technical guidance on global regulatory requirements to product development terms.
•Evaluates risks of product and clinical safety issues during clinical phases and recommend regulatory solutions.
•Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans for changes that do not require submissions.
•Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans.
•Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases.
•Provides regulatory guidance on strategy for proposed product claims/labeling.
•Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims.
•Manages electronic (eCTD) and paper registration development.
•Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions.
•Manage day-to-day regulatory processes to ensure issues are appropriately evaluated.
•Support annual budgets and quarterly forecasts. Make necessary changes with appropriate management involvement.
•Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met.
•Serve as Subject Matter Expert for regulatory processes.
•Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations.
•Establish a standard process to ensure appropriate resolution and management of the responsible task owner.
•Manage and provide updates for regulatory metrics. Implement appropriate enhancements.
•Represent regulatory processes during internal and external audits.
•Define targets, KPIs, performance objectives, etc. 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 to the team.
•Maintain a high level of team engagement.
•Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and international requirements.
•Act as a champion for international integrations leading the initiative and assessment through LATAM region.
•Define Regulatory strategy for the region.
•Centralize and develop regional Regulatory strategy and planning.
•Support the preparation of registration dossiers.
•Partner with Design Divisions (point of contact for LATAM RA).
•Lead and support Regulatory Affairs pre-market processes harmonization across the region.
•Centralize regional regulatory intelligence.
•Ensure regulatory product portfolio integration in mergers and acquisitions.
•Promote portfolio rationalization across the region.
•Lead the process of new registrations and launches across the region.
What you need:
•BSc degree in relevant field required.
•Advanced English skills required.
•Advanced Spanish skills required.
•Master's Degree or equivalent desired.
•RAC desired.
Knowledge/Competencies
• Demonstrated project management and time management skills, writing, coordination, and execution.
•Demonstrated knowledge and application of regulatory requirements, including Medical Device Directive, as well as other international requirements pertaining to the medical device industry.
•Demonstrated ability to effectively prioritize and manage multiple project workloads.
•Demonstrated ability to lead and develop employees and building effective teams.
•Demonstrated leadership skills.
•Experience with recruiting, hiring, and developing talent.
•Demonstrated process improvement skills.
•Demonstrated ability to manage complex and multi-region projects within a matrix environment.
•Demonstrated ability to collaborate effectively with and lead cross-functional teams.
•Influence across the organization.
•Coordinate, support, and lead technical and scientific RA activities.
•Undertaking assignments that are broad in nature, requiring originality and ingenuity.
•Ability to take unreviewed action or decisions on business-critical matters.
•Clearly conveys information to peers, supervisors, and other stakeholders across the LATAM organization, Design Divisions and third-party distributors.
•Leads meetings with regulatory agencies, internal and external audits, and other stakeholders.
•Prepares briefings and other information documents.
•Communicates information and advises on RA requirements to other departments and business units.
•Engages in communication with regulators and other key stakeholders on both routine and business critical matters.
•Creates clarity and direction amid complexity and develops solutions for self, colleagues, and the organization.
•Seeks out diverse ideas, opinions, and insights, and applies them in the workplace.
•Connects and relates well with people who think and act differently than oneself.
•Embraces scrutiny and accepts feedback as opportunity to learn and improve.
•Preparation of RA metrics for reporting purposes.
•High attention to detail and process consciousness.
•Strong IT skills, including Microsoft Office.
