Johnson & Johnson Careers

Post Market Surveillance Officer

Santa Ana, California
Quality Assurance


Job Description

Requisition ID: 1704180910

Johnson & Johnson Vision (JJV), a member of Johnson & Johnson's Family of Companies is recruiting for Post Market Surveillance Officer, to be located in Santa Ana, CA with consideration for remote locations in the United States.
JJV, is a worldwide company with operations in the United States, Japan, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Since we introduced soft disposable contact lenses in 1988, and through the acquisition of Abbott Medical Optics in 2017, no other manufacturer has matched the aggressive expansion of our wide-ranging Surgical Vision (Cataracts and Lasik portfolio) and Vision Care (ACUVUE and Consumer Eye Health solutions) family of products. Our associates around the world are committed to expanding the JV brand, and fortifying our position as the worldwide leader in total eye healthcare solutions.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
You, the Post Market Surveillance Officer will: - Uses clinical ophthalmic experience to act as a liaison and key resource for customers and eye care professionals regarding product performance issues.
- Investigate & resolve more complex complaints that may require a higher level understanding such as: legal action, complaints posted on social media, complaints coming from KOL feedback, complaints where FDA and other regulatory bodies have asked additional questions.
- Promptly respond to high risk/sensitivity complaints.
- Partner with Medical Safety by providing robust adverse event details and other activities as needed.
- Support the commercial sales reps with complaints that are impacting accounts or the brand.
- Partnering and supporting customer facing sales personnel to ensure accounts are not at risk of being lost.
- Creating awareness amongst the commercial team on expectations regarding investigation results.
- Ability to have “doctor to doctor” conversations if necessary.
- Represent JJSV PMSS during regulatory inspections
- Provide clinical guidance for complaint investigation to complaint processing associates.
- Coordinates and dictate the cadence or prioritization of investigations in association with manufacturing sites and complaint lab
- Adheres to GMP regulations within complaint and medical files and other documents within the department.
- Leads or participates in other activities as required including reviewing new / emerging regulations, project teams, training new associates, process improvements, etc.
Qualifications

Requirements:
- MD or DO Degree required.
- 10 years medical related experience is required.
- Ophthalmology experience (ophthalmologist or optimistic) is required.
- Minimum of 10 years work experience.
- Strong written and oral communication skills in English; multi-lingual skills are desirable
- This position will require 10-30 % travel (includes both international and domestic travel)
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.


Primary Location
United States-California-Santa Ana
Organization
AMO US Holdings, Inc.. (6234)
Job Function
Quality Assurance
Requisition ID
1704180910