Customer Quality Regulatory Specialist

Job description

Job Description

Requisition ID: 6631190205


DePuy Synthes, a member of Johnson & Johnson Family of Companies, is recruiting a Customer Quality Regulatory Specialist.

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

The Customer Quality Regulatory Specialist will be responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR and Vigilance submissions to applicable health authorities. This includes review of information for reportability and being accountable for the accuracy of the information submitted.

As the Customer Quality Regulatory Specialist, you will:
• Ensure timeliness of medical device and vigilance reporting activities in accordance to procedures, standards, and applicable regulations.
• Under limited supervision, review and assess the complaint information to determine reportability to various regulatory agencies (e.g. FDA, Vigilance).
• Support other cross function teams on an ad-hoc basis regarding medical device and vigilance reporting.
• Provide support during external and internal audits (e.g FDA, TUV, BSI, MDSAP)
• Remain informed of new or revised regulations and/or guidelines to support EUMDR activities.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
• Perform other related duties and responsibilities, on occasion, as assigned
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Desired profile

Qualifications
• A minimum of a Bachelor's Degree is required; a focus on the healthcare, science, or technical field is preferred.
• A minimum of 2 years of relevant experience supporting complaint handling investigations, medical device reporting, product evaluation, or related work.
• Experience working in a broader enterprise/cross-division business unit model is preferred.
• Knowledge of global regulation for medical device reporting and medical terminology is a plus.
• Proficient computer skills (MS Office) are required.
• Strong written and oral communication skills are required.
• Must be able to work well independently and on teams in a fast paced environment while maintaining accuracy.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to maintain regular and predictable attendance is required
• Ability to travel up to 10% of the time to domestic destinations is required.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
United States-Pennsylvania-West Chester-
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Quality Assurance
Requisition ID
6631190205