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Paid time off Who We Are WRS is a medical device company headquartered in Ann Arbor, MI. We offer ... remote position.
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Paid time off Who We Are WRS is a medical device company headquartered in Ann Arbor, MI. We offer ... remote position.
Vision insurance Who We Are WRS is a medical device company headquartered in Ann Arbor, MI. We ... remote position.
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Remote Medical Device Labeling information
What is the difference between Remote Medical Device Labeling vs Medical Device Quality Assurance Specialist?
| Aspect | Remote Medical Device Labeling | Medical Device Quality Assurance Specialist |
|---|---|---|
| Credentials | Regulatory knowledge, labeling certifications | Quality standards, compliance certifications |
| Work Environment | Remote, documentation-focused | Office or manufacturing settings, audits |
| Industry Usage | Regulatory submissions, labeling compliance | Product quality, process improvement |
Remote Medical Device Labeling focuses on ensuring product labels meet regulatory standards, often working remotely on documentation. Medical Device Quality Assurance Specialists concentrate on maintaining product quality and compliance through audits and process controls, typically working in physical environments. Both roles are essential in the medical device industry but differ in their primary focus and work settings.
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Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 9 days ago
Johnson & Johnson rating
8.1
Based on 102 frontline employees who took The Breakroom Quiz
32nd of 71 rated pharmaceutical
Job description
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
Job Function:
Technology Enterprise Strategy & Security
Job Sub Function:
Solution Architecture
Job Category:
Scientific/Technology
All Job Posting Locations:
Albuquerque, New Mexico, United States of America, Albuquerque, New Mexico, United States of America, Alexandria, Virginia, United States, Atlanta, Georgia, United States, Austin, Texas, United States, Baltimore, Maryland, United States, Billings, Montana, United States, Birmingham, Alabama, United States, Bismarck, North Dakota, United States, Bloomington, Illinois, United States, Boise, Idaho, United States, Boulder, Colorado, United States, Bridgeport, Connecticut, United States, Burlington, Vermont, United States, Charleston, South Carolina, United States, Charleston, West Virginia, United States, Charlotte, North Carolina, United States, Chattanooga, Tennessee, United States, Cleveland, Ohio, United States, Concord, New Hampshire, United States, Danvers, Massachusetts, United States of America, Detroit, Michigan, United States, Dover, Delaware, United States, Flagstaff, Arizona, United States, Indianapolis, Indiana, United States {+ 23 more}
Job Description:
We are searching for the best talent for a Principal Product Security Engineer to be located in Danvers, MA or Raritan, NJ. Remote work options may be considered on a case-by-case basis and if approved by the Company.
Are you passionate about security and interested in joining a community of collaborative colleagues working in a Patient First! culture? If that’s you, we have an immediate opportunity for a Principal Product Security Engineer to join the newly formed Product Security team to help ensure security is implemented by design for this top-performing medical device company. This is an exciting opportunity to impact development initiatives that will shape future product development and industry standards. You will own the Product Security process that includes both pre-market and post-market processes engineering teams leverage throughout the product development lifecycle. If you are eager to leverage your security risk and compliance skills to make a difference and directly impact patient lives, this could be perfect for you.
Primary Duties and Responsibilities
- Being at the office in Danvers MA for a minimum of 3 days per week (for candidates within commutable distance to site).
- Partner with engineering teams (cloud, console, pump, etc.) to drive successful adherence to Abiomed’s product security policies, processes, program objectives.
- Create, update, and improve product security processes.
- Act as a SME on cyber security matters and provide guidance to development teams.
- Advocate for proactive inclusion of cyber security input into all phases of the product life cycle, process improvements, CAPAs, strategic product road map planning.
- Deliver documentation for pre-market product development activities including security plans, architecture diagrams, data flow diagrams, threat models, security requirements, Design for Security, SBOM, and risk management documentation.
- Drive and monitor and post-market vulnerability management activities, with adherence to strict timelines.
- Support compliance certification activities, such as SOC2, FedRAMP, ISO 27001, etc.
- Identify, research, evaluate, and integrate new compliance requirements, industry standards, and best practices into the product security programs.
- Maintain relationships with Abiomed’s Information Sharing and Analysis Organizations.
- Guide teams to make decisions that balance business needs with medical device security objectives.
- Work across organizational boundaries and exhibit empathy with customers, both internal and external.
- Perform other related duties and responsibilities, as assigned.
Qualifications
Required:
- Bachelor’s degree
- 5+ years industry experience in Information Security.
- Working knowledge of regulatory standards and compliance frameworks (e.g., NIST Cybersecurity Framework, ISO27001, SOC2, HIPAA, GDPR).
- Experience with security risk management techniques.
- Demonstrated organizational skills, attention to detail, the ability to handle multiple assignments simultaneously in a timely manner and be able to meet assigned deadlines.
- Committed to working with a sense of urgency and embracing new challenges.
- Strong communication and interpersonal skills.
Preferred:
- Experience working in a regulated environment, FDA-regulated
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.
#JNJTech
#LIHybrid
#LIRemote
The anticipated base pay range for this position is :
$100,000 - $172,500.
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. 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)). 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. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
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