Work Flexibility: Remote or Hybrid or Onsite
Join our team as a Senior Regulatory Affairs Specialist!
This person will for a key part of our Regulatory Affairs function, servicing the GSA region and will be exposed to a broad range of Stryker products.
Do you have a strong understanding of regulatory framewrok? Are you looking for a challenging role that will push your knowledge in this sector? Apply today!
Key Areas of Responsibility:
Executes post-market surveillance activities with focus on Complaint Handling, Product Field Actions (PFA/FSCA), Commercial Holds and related Post Market activities (PMS) activities.
Coordinates the intake, processing, follow-up and closure of product complaints and ensures complete and timely documentation in applicable quality systems.
Coordinates local execution of Product Field Actions, recalls and Commercial Holds, including assessment of local impact, containment, customer communication, reconciliation, product return/destruction and closure activities.
Reviews product scope, distribution and inventory information and coordinates required actions with relevant local, regional and divisional stakeholders.
Acts as an operational interface between RAQA, Central/Regional PMS, Legal Manufacturers/Divisions, Customer Service, Sales, Supply Chain, Distribution/Warehouse and other relevant stakeholders.
Proactively coordinates and follows up on outstanding actions, clarifies responsibilities, and escalates delays, gaps or compliance risks as appropriate.
Supports communication with Competent Authorities and other external stakeholders on post-market surveillance matters.
Maintains systems to track, manage and report product complaints, field actions, Commercial Holds and other product-associated events.
Monitors assigned cases, timelines and execution status and ensures activities are completed in line with applicable procedures and defined timelines.
Supports complaint trending
Monitors the post-market environment, including applicable regulations, guidance and other relevant information.
Supports the development, implementation and continuous improvement of PMS procedures, SOPs, work instructions and training materials.
Provides PMS process guidance and operational support to internal stakeholders and promotes awareness and understanding of Complaint Handling and PFA/HOLD processes.
Supports preparation for regulatory inspections, internal and external audits and other PMS-related assessments.
Prepares and monitors RAQA/PMS metrics and KPIs and supports identification of trends, backlogs and opportunities for continuous improvement
Identifies opportunities to improve the effectiveness and efficiency of PMS processes and supports implementation of improvement activities across RAQA.
Education / Work Experience:
BSc in Engineering, Science, Regulatory Affairs, Quality Management, Business Administration or related degree; equivalent relevant professional experience may be considered.
2+ years’ relevant experience in Regulatory Affairs, Quality Assurance, Post-Market Surveillance, Complaint Handling or another regulated medical-device environment.
Experience working in a cross-functional and international matrix organization preferred.
Knowledge / Competencies:
Good understanding of Post-Market Surveillance, Complaint Handling, Vigilance, Product Field Actions/FSCA, recalls and Commercial Holds within the medical-device environment.
Strong project, time and priority management skills, with the ability to independently manage multiple parallel PMS activities and deadlines.
Resilient and comfortable working in an environment with changing priorities, urgent activities and competing deadlines.
Strong problem-solving skills and ability to exercise sound judgement when dealing with incomplete or changing information.
Demonstrates ownership and drives assigned activities from initiation through follow-up and completion with minimal supervision.
Strong coordination and stakeholder-management skills with…