Senior Post Market Surveillance Specialist

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We are searching for the best talent for a Senior Post Market Surveillance Specialist to be based in Santa Clara CA.

About MedTech

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at The Senior Post Market Surveillance Specialist is responsible for performing domestic and international product surveillance activities for all medical devices manufactured marketed distributed and serviced by Auris Health Inc. Primary responsibilities include activities associated with the complaint handling program regulatory reports and field actions. This position reports to the Senior Manager Quality Management System.

You will be responsible for:

• Manage daily workflows for all assigned complaint records.

• Communicate with Service and Sales teams or other internal personnel to identify details related to complaint information and event specifics.

• Determine reportability of complaints and submit applicable regulatory reports to the FDA and other Regulatory Agencies as applicable.

• Perform Good Faith Effort for product return and obtain required information for complaint assessment and evaluation.

• Review investigation records to ensure analysis documentation is appropriate and complete.

• Review complaint records to ensure all the applicable records are created and completed.

• Ensures customer complaint response letters are completed and communicated in a timely and comprehensive manner.

• Understand team performance metrics and strive to achieve targets and goals.

• Perform ad hoc reporting and researching of post market data.

• Manage and coordinate documentation for field actions as required.

• Support and participate in internal and external audits.

• Other related duties may be assigned.

Qualifications/Requirements:

• Preferred: B.A./B.S. in in a Life Science Engineering or similar degree or equivalent combination of education and experience.

• 5 years of experience in a commercial medical device company preferably within Quality. 2 years in complaint handling.

• Must be highly organized with the ability to manage multiple activities simultaneously and effectively prioritize projects and tasks.

• Familiarity with the applicable US FDA Regulations (21 CFR Part) EU Medical Device Regulations and ISO 13485 standards.

• Excellent written and verbal communication skills.

• An approachable individual who provides a high level of teamwork and cross-functional collaboration.

• Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820.

Johnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

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Senior IC