Sr. Regulatory Operations Specialist (Remote) - Shockwave ID-1560
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com
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Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Santa Clara, California, United States of America
Job Description:
Johnson & Johnson is hiring for aSr Regulatory Operations Specialist - Shockwave Medical to join our team located in Santa Clara, CA or Remote US.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
Position Overview
The Senior Regulatory Operations Specialist is an individual contributor who will help secure and retain global regulatory approvals for medical devices by archiving, creating, and maintaining specific categories of regulatory documentation and data. Works closely and partners with Regulatory colleagues and other internal departments to meet assigned deliverables and identify areas of improvement within Regulatory Operations efficiently and effectively. The function of the Senior Regulatory Affairs Specialist, Operations, includes providing submission publishing/verification support and Regulatory compliance support.Under direction of responsible Regulatory Affairs Management, works independently with minimal oversight.
Essential Job Functions
- Publisher for worldwide regulatory submissions in compliance with geography-specific regulatory requirements
- Verify and qualify review of submissions and other responses to regulatory agencies
- Archive correspondence sent to and received from Regulatory Agencies and Notified Body
- Track original and renewals of annual licenses and registrations/listings, and collect/organize/ disseminate, when required, registration renewal documentation
- Manage worldwide regulatory compliance with UDI requirementsWork with cross-functional teams, to assist with interpretation and compliance, regarding applicable standards and other regulatory agency requirements (e.g., ISO and IEC standards, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents).
- Develop new regulatory operations policies, processes and SOPs and may train key personnel
- Author and route document change orders via document control system
- Provide other country specific regulatory support
- Contribute to process improvement projects
- Maintain the Department intranet up to date
- Ensure personal compliance with applicable company policies and procedures
- Provide audit backroom support
- Knowledge of business functions and cross group dependencies/relationships
- Provide other country specific regulatory support
- Communicates, prepares, and negotiates with internal stakeholders. Properly interprets and applies regulatory requirements
- Provide support for product recalls and recall communications
- Evaluate import/export requirements
- Ensure personal compliance with applicable company policies and procedures
- Write and edit technical documents
- Ability to perform multiple tasks concurrently with accuracy
- Other duties as needed
Qualifications
- Bachelor's degree or equivalent experience. Bachelor's degree in science, math, engineering, or medical fields is preferred.
- Minimum 5 years of experience in a regulatory position in a regulated healthcare industry or equivalent.
- Ability to work collaboratively in a fast-paced environment while managing multiple priorities.
- Highly proficient with MS Word, SharePoint (or equivalent), Excel, Adobe and Power Point. Proficient with Word Macros.
- Ability to work collaboratively in a fast-paced environment and to perform multiple tasks concurrently with accuracy
- Flexible with changing priorities, ability to manage multiple tasks, prioritize and schedule work to meet business needs and timelines
- Organized, detail oriented, with good planning and time management skills
- Ability to complete short- and long-term projects of moderate complexity with some guidance
- Ability to think analytically with good problem-solving skills
- Clear and effective verbal and written communication skills with various levels of the organization
- Familiar with databases/systems (CECATS, FDA Establishment Registration and Listing, eSTAR, eSubmitter, eValidator, EUDAMED, GMDN, GUDID)
- Notary Public is a plus
Additional Information:
The anticipated salary range for this position is:
Outside Bay Area: $89,000 - $143,750
Bay Area: $103,000 - $165,600
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
- Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
- 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
- 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
The compensation and benefits information set forth in this posting applies to candidates hired in the United States.
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.
The anticipated base pay range for this position is :
"Rest of US: $89,000- $143,750 BA: $103,000-$165,600"
Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
