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Johnson & Johnson MedTech Electrophysiology, a member of Johnson & Johnson family of companies, is recruiting for a Sr. Specialist, Scientific Operations to join the team in Irvine, CA.

The J& J MedTech Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.

The Scientific Operations (SciOps) Sr. Specialist, will provide input and support to related functions ensuring the delivery of key regulatory and medical documents. Specifically, the Sr. Specialist will lead the review of Clinical Evaluations (CERs), State of the Art Assessments (SOA), Literature Reviews, Summaries of Safety and Clinical Performance (SSCP), and Periodic Safety Updates (PSUR) for the MedTech Electrophysiology business unit. Furthermore, the Sr. Specialist will support interactions with the Notified Body and applicable Health Authorities and the drafting and alignment on response strategy and execution.

You will provide leadership and maintain relationships through extensive partnering, benchmarking, and forming strategic alliances with cross functional business partners to drive key business goals and objectives. Additionally, you will lead SciOps activities/projects, including those supporting the Eudamed Readiness strategies for SSCP and PSURs in support of the EU MDR.

Responsibilities:

• Support a team of managers and medical writers to strategize, synthesize and analyze product related safety and performance data, draft reports, coordinate approvals, and when applicable manage submissions to the Notified Body.
• Perform technical reviews ensuring the accuracy and compliance of Scientific Operations deliverables including Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Literature Review Protocol (LRP), Literature Review Report (LRR), Summary of Safety and Clinical Performance (SSCP), and Periodic Safety Updates Report (PSUR) documents.
• Track and trend Notified Body inquiries within business unit to identify trends, improve processes, and increase speed to market. Translate insights into viable processes and solutions that create value.
• Ensure the Scientific Operations deliverables are linked to appropriate Quality Systems and Regulatory documents (e.g. Risk Management, PMS, etc.) to make certain information is consistent and accessible where needed. S/He will develop, implement and manage an effective communication model for Scientific Operations deliverables with cross functional business partners.
• Assist in the development of schedules to ensure operating company deliverable timelines are met.
• Participate in workshops and lead projects/ initiatives to help define processes globally and keep abreast of MDR regulatory requirements and industry trends/practices, ensuring that a proactive ongoing review of processes and procedures is in place to maintain a strong regulatory profile while continually improving process efficiencies.
• Support audits and inspections pertaining to Scientific Operations processes and reports.
• Partner with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R& D, and Regulatory Affairs relating to the Scientific Operations deliverables

Qualifications

Required:

• Minimum of a Bachelor’s degree (University Degree), in Life Sciences, Engineering or related subject area.
• Minimum of 5 years of experience in a regulated environment including 3 years of direct experience with medical devices in the fields of technical or medical writing, post market surveillance, clinical research, or product risk management.

Preferred:

• Knowledge on physiology and common outcomes of electrophysiology
• Experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and CER document creation
• An advanced degree, MS, PhD, RN, or MBA.
• Demonstrated knowledge and experience in quality regulatory compliance, complaint handling, adverse event reporting, medical device risk management processes, and experience with common bio statistical methods
• Process Excellence / Six Sigma training or certifications.

• This position is eligible to participate in the Company’s long-term incentive program
• Employees are eligible for the following time off benefits:
  • Vacation – up to 120 hours per calendar year
  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
  • Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
  • Additional information can be found through the link below. https: //www.careers.jnj.com/employee-benefits

• 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 and 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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

This position is located in Irvine, CA.

The anticipated base pay range for this position is:

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