Summary Description of this Job: Directs the planning, preparation and facilitates the timely submissions of all MDR, Vigilance and other regulatory reports to the appropriate regulatory authorities globally. Guides regulatory reporting activities globally, provides clinical expertise for PMS related activities. Identifies, communicates and tracks high priority issues relating to safety, complaints and systemic customer satisfaction. This position will hire staff, and conduct performance reviews and fulfill other management responsibilities. Successful candidate will have proven organizational skills with track record of achieving positive results.
Essential Duties and Responsibilities:
- Communicates with customers to establish a full understanding of alleged adverse events.
- Analyzes medical device reporting data to identify trends. Notifies designated internal personnel with appropriate findings and
recommendations. Enables rapid and effective escalation and investigation of potential safety related issues.
- Responsible for leading the Product Experience analysts’ team, manages workflow and processes. Supports the Product Experience Group in leading and directing the global process activities
- Trains direct reports to ensure proper implementation and use of quality tools and procedures as required.
- Manages complaint workflow and the processing of complaints within software applications
- Interacts with Regulatory Authorities to answer follow-up questions, provide investigation details
- Provides guidance on clinical risks and outcomes associated with medical device malfunctions
- Assist or lead general compliance activities as required.
- Other duties as assigned
Bachelor’s Degree in science, math or engineering discipline. General knowledge of basic physiology, high level of research, analytical and problem solving skills; ability to prioritize for maximum results (multitask management)
Excellent communication skills, ability to manage multiple priorities, creative problem-solving ability; excellent oral and written presentation skills; team oriented; good planning and organizational skills. General knowledge of basic human physiology.
Demonstrated interpersonal skills to successfully partner with individuals to build relationships with business contacts, customers and regulatory entities. Demonstrated capability to direct employees working with cross-functional teams to resolve customer issues *
Capability to train reports on QSR, Medical Device Directive, and ISO Quality System Standards. EU MDR understanding is a plus. Proven excellent analytical, decision making, and problem-solving skills to successfully define problems, collect data, establish facts and draw accurate conclusions, and to train and manage direct reports to do the same.
CQA or CBA or RABSQA required. CQE and CQMgr/OE certifications preferred.
Minitab software or similar statistical analysis software tool; General Microsoft Office applications. Work experience with electronic QMS software.
Minimum 7 – 10 years of work experience in regulated healthcare environment (ISO 13485:2016 and 21 CFR 820); past participation in Notified Body and FDA audits. Strong knowledge of applicable standards and guidance documents; ability to lead and mentor in a team environment.
If interested in this position, please send copy of your resume and contact information to Kelsey George at the following address: Kelsey.George@argonmedical.com.