Top 37 Post market surveillance Jobs in New Jersey

Manager- Post Market Surveillance (Recall)
CooperSurgical —Livingston, NJ
- $107,000 - $150,000 a year
- Full-time
- Remote
- 5 years
- Presentation skills
- Mentoring
- Health insurance
- Paid time off
Post Doc Assoc - Multiple Vacancies
Rutgers University —Piscataway, NJ
- $20,000 - $200,000 a year
- Full-time
- Medicine
- Addiction Medicine
- Mid-level
- Paid holidays
- Dental insurance
13d
Post Doctoral Associate
Rutgers University —New Brunswick, NJ
- $63,968 - $200,000 a year
- Full-time
- Doctoral degree
- University
- Psychology
- Paid holidays
- Dental insurance
8d
Junior Quality Engineer, Design Assurance
Orthofix —Verona, NJ
- $35 an hour
- Full-time
- English
- Office
- Travel
- Health insurance
Junior Quality Complaints Engineer
Orthofix —Verona, NJ
- $30 an hour
- Full-time
- English
- Office
- Master's degree
- Health insurance
12h
Director, Quality Systems (SM)
BD —Franklin Lakes, NJ
- $211,900 - $339,000 a year
- Bachelor of Science
- Office
- Bachelor's degree
7d
Telemetry Technician, Telemetry Services
Trinitas Regional Medical Center —Elizabeth, NJ
- $23.57 an hour
- Evening shift
- Hospital
- BLS Certification
- Mid-level
Security Force Lieutenant I
Institute for Defense Analyses —Princeton, NJ
- $42,000 - $67,000 a year
- Overtime
- Mid-level
- High school diploma or GED
- Criminal background check
- Paid parental leave
- Tuition reimbursement
Vice President, Trading Surveillance Compliance
moomoo —Jersey City, NJ
- $120,000 - $160,000 a year
- Full-time
- 7 years
- Office
- Analysis skills
- Paid holidays
- Health insurance
Quick Apply
Quality Assurance Specialist
Keystone Industries —Gibbstown, NJ
- $80,000 - $100,000 a year
- Monday to Friday
- Microsoft Excel
- Microsoft Outlook
- 5 years
- Health savings account
- Paid holidays
Quick Apply
Medical Device Complaint Trending Expert (Any Facility)
Integra LifeSciences —Princeton, NJ
- $81,650 - $112,700 a year
- Email
- Oracle
- 5 years
- Engineering
- Disability insurance
- Health insurance
Sr. Specialist, Regulatory Affairs
Metagenics —Jersey City, NJ
- $125,500 - $140,000 a year
- Full-time
- Hybrid work
- Microsoft Excel
- Office
- Master's degree
- Health savings account
- AD&D insurance
Associate Director, Patient Safety Scientist
Bristol-Myers Squibb —Madison, NJ
- $150,300 - $182,125 a year
- Email
- Hybrid work
- Medicine
- 6 years
- Bachelor of Science
- Paid holidays
- Disability insurance
Security Officer, 2nd shift, Part Time, 24 hrs/wk
Virtua Health —Camden, NJ
- $18.69 - $26.01 an hour
- Part-time
- CPR Certification
- Hospital
- Customer service
- AD&D insurance
- Disability insurance
Security Officer, 3rd shift, Per Diem
Virtua Health —Camden, NJ
- $18.69 - $26.01 an hour
- Per diem
- Hospital
- Customer service
- Mid-level
- AD&D insurance
- Disability insurance
Vice President, Corporate Quality Systems
Integra LifeSciences —Princeton, NJ
- $225,400 - $316,250 a year
- Email
- Up to 50% travel
- Writing skills
- 11+ years
- Disability insurance
- Health insurance
14d
Scientific Director / Senior Medical Director, Multiple Myeloma (International Medical Affairs)
AbbVie —Florham Park, NJ
- $182,000 - $346,000 a year
- Full-time
- Hybrid work
- Medicine
- English
- Doctor of Philosophy
- Paid holidays
- Health insurance
Director, Quality Data Analytics
Integra LifeSciences —Princeton, NJ
- $166,750 - $228,850 a year
- Email
- 7 years
- Computer Science
- SQL
- Disability insurance
- Health insurance
Director, Network Safety Officer
Hackensack Meridian Health —Iselin, NJ
- From $145,787.20 a year
- Full-time
- 6 years
- Hospital
- Engineering
- Health insurance
- Dental insurance
12d
Cultural Property Security Supervisor
Princeton University —Princeton, NJ
- $70,000 - $82,000 a year
- 8 hour shift
- Background check
- Military
- Word processing
2h

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Manager- Post Market Surveillance (Recall)

CooperSurgical -
Livingston, NJ

Apply Now

Job Details

Full-time
$107,000 - $150,000 a year

Benefits

Health insurance
Paid time off
Parental leave

Qualifications

Medical writing
Stakeholder engagement
Performance improvement leadership
Healthcare incident reporting system
Process audits
ISO standards
5 years
Safety regulations
Bachelor's degree in biomedical engineering
Metrics Reporting
Quality reports
Team development
Key Performance Indicators
Bachelor's degree in biomedical science
Policy & process development
Bachelor's degree in engineering
Presentation skills
Compliance documentation
Quality compliance management
Mentoring
Organizational skills
Biomedical regulatory compliance
Regulatory submissions
Computer skills
Management reporting
Managing projects
Operational excellence initiatives
Process improvement planning
Senior level
Regulatory audits

Full Job Description

The Manager, Post Market Surveillance- Recall is responsible for CooperSurgical, Inc.’s (CSI) global Post Market Surveillance Recall activities, working with various internal/external stakeholders, and managing the Recall team. This position is responsible for managing CooperSurgical’s global Recall activities, including but not limited to preparation of Health Hazard Evaluations (HHEs), executing Corrections and Removals, interacting with regulatory authorities, and identifying continuous improvement opportunities in the Recall process and implementing updates. Responsible for managing and mentoring members of CSI’s Recall team.

About CooperSurgical CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com. Work location: Trumbull, CT (on-site), Livingston, NJ (on-site) or Remote in US (if not residing in NY-metro area)

Knowledge, Skills and Abilities:

Knowledge and ability to lead Recalls from initiation to closure in a medical device or pharmaceutical organization.
Excellent analytical, written and verbal skills, including strong presentation skills.
Ability to communicate with and influence various stakeholders at all organizational levels.
Ability to balance multiple projects/tasks, with a high degree of initiative and flexibility to adapt in changing environments.
Expert knowledge of FDA regulation 21 CFR 806, working knowledge of 21 CFR 803, 805, 806, 820 and ISO standards 13485, 14971, and EU MDR 2017/745, MDCG 2023-3.
Understanding of Quality Management Systems and the associated interrelationship with Recall process.
Ability to work efficiently in an e-QMS and incorporate technology (e.g., Artificial Intelligence tools) into the Recall process.

Work Environment:

Prolonged periods of sitting, especially in front of a computer.

Experience:

4+ years leading HHEs and Recall decisions/Recall strategy.
Experience writing Recall communications.
Experience presenting as Recall owner in audits/inspections.
5+ years of Quality Management Systems experience.
Experience in Risk Management preferred.

Education:

Bachelor’s degree in Biomedical Science, Engineering or a related field preferred.

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at [email protected]

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $107,000 - $150,000. The actual base pay includes many factors, and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.

Leads CSI Recall process for assessment & execution of corrections and removal of a wide variety of medical products (e.g., medical devices, IVDs).
Responsible for all aspects of CSI’s Recall process, including but not limited to preparation of required regulatory documentation and internal/external communications related to Recalls (e.g., Health Hazard Evaluation, Recall Execution Strategy, Field Safety Communications, Recall Termination Requests).
Manages Health Hazard Evaluations from initiation through completion, leading cross-functional teams through process, ensuring timely completion.
Collaborates closely with leadership in Quality & Medical Affairs on the development/approval of HHEs.
Provides direction/guidance to Recall team on execution of Recalls with customers, distributors, and regional RAQA representatives.
Leads all Recall reporting activities (including 806/FSCA reports) to US FDA, EU Competent Authorities and other Health Authorities globally, as needed. Maintains active communication with CSI’s Authorized Representative(s) and Notified Body, as required.
Ensures reporting requirements are compliant with CSI Policy in accordance with applicable global laws & regulations.
Collaborates closely with CSI cross-functional leaders across various Business Units & Global Markets.
Resolves Regulatory Agency/Health Authority requests in relation to reportable Corrections and Removals, ensuring timely closure/termination.
Maintains and monitors HHE/Recall Key Performance Indicators (KPI), escalating and reporting progress to CSI Leadership on HHEs/Recalls as appropriate/required per local QMS procedures.
Establishes and maintains department metrics that complement CSI goals, targets, and objectives.
Assesses and identifies process improvements, developing and implementing business solutions related to Recall process.
Serves as CSI’s Recall Process Owner and Subject Matter Expert, leading all front room Recall interactions during Notified Body MDSAP audits/FDA inspections.
Ensure Recall procedures and processes are compliant with all applicable global regulations.
Stays apprised of latest developments in the global regulatory landscape related to Recalls.
Manages, develops and mentors Recall team, creating an atmosphere of encouragement, motivation, and growth opportunity.
Performs other duties as assigned.

Travel:

This position may require 0-10% domestic and/or foreign travel.

Apply Now

Refine Your Search

post market surveillance jobs in new jersey

Manager- Post Market Surveillance (Recall)

Post Doc Assoc - Multiple Vacancies

Post Doctoral Associate

Junior Quality Engineer, Design Assurance

Junior Quality Complaints Engineer

Director, Quality Systems (SM)

Telemetry Technician, Telemetry Services

Security Force Lieutenant I

Vice President, Trading Surveillance Compliance

Quality Assurance Specialist

Medical Device Complaint Trending Expert (Any Facility)

Sr. Specialist, Regulatory Affairs

Associate Director, Patient Safety Scientist

Security Officer, 2nd shift, Part Time, 24 hrs/wk

Security Officer, 3rd shift, Per Diem

Vice President, Corporate Quality Systems

Scientific Director / Senior Medical Director, Multiple Myeloma (International Medical Affairs)

Director, Quality Data Analytics

Director, Network Safety Officer

Cultural Property Security Supervisor

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