Top 49 Post market surveillance Jobs in Remote

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
Manager, Loss Prevention Training
Ross Stores —Remote
- $81,000 - $121,800 a year
- Hybrid work
- Background check
- 5 years
- Mid-level
22h
Contract/Acquisition Specialist (Remote)
DLS Engineering —Remote
- $65,000 - $75,000 a year
- Full-time
- Remote
- Background check
- Mid-level
- 3 years
- Disability insurance
- Health insurance
Quick Apply
Statistical Analyst
Applied Research and Analysis Company (ARAC) —Remote
- $80,000 - $100,000 a year
- Full-time
- Remote
- Bachelor's degree
- Mentoring
- Senior level
- Paid parental leave
- Health insurance
Quick Apply
7d
Sr Quality Engineer - Post Market Data Analyst
Integrated DNA Technologies (IDT) —New York, NY
- $66,000 - $115,500 a year
- Full-time
- Remote
- Computer Science
- Engineering
- 3 years
- Health insurance
- Dental insurance
6d
Trade Surveillance Analyst 1 — Financial Crimes Department
Alpaca —New York, NY
- Remote
- 5 years
- Mid-level
- Analysis skills
- Health insurance
Quick Apply
6d
Senior Medical Writer
Medtronic —North Haven, CT
- $108,000 - $162,000 a year
- Full-time
- Remote
- Surgery
- Mid-level
- Master's degree
- Health savings account
- Employee stock purchase plan
4d
Acquisition Specialist (Junior) Remote
GCC Technologies, LLC —Detroit, MI
- Remote
- High school
- English
- Mid-level
Acquisition Management Support Subject Matter Expert (SME)
Grey Street Consulting LLC —Washington, DC
- Remote
- Mid-level
- Bachelor's degree
- Continuous improvement
- Health insurance
- Dental insurance
Senior Director, Post Market Monitoring
Olympus —Westborough, MA
- $144,541 - $216,812 a year
- Full-time
- Remote
- 7 years
- Engineering
- Doctor of Philosophy
- Paid parental leave
- Paid holidays
11d
Clinical Product Surveillance Specialist
Medline Industries —Northfield, IL
- $79,000 - $119,000 a year
- Full-time
- Remote
- Nursing
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- 401(k)
National - Regional Sales Manager - Caesars Entertainment (Remote)
Caesars Entertainment —Las Vegas, NV
- Full-time
- Remote
- Background check
- Bachelor of Science
- Mid-level
13d
Medical Safety Manager - EI
Philips —Remote
- $133,000 - $237,000 a year
- Full-time
- Nursing
- Medicine
- 7 years
- Health savings account
- Employee stock purchase plan
Sr Manager, Regulatory Affairs
Merative —Remote
- $144,632.60 - $216,948.90 a year
- Full-time
- 5 years
- Research
- Analysis skills
- Health insurance
- Dental insurance
Security Systems Designer - 100% Remote
IES Communications —Tempe, AZ
- $100,000 - $125,000 a year
- Full-time
- Remote
- Microsoft Excel
- 5 years
- Residential
Senior Specialist, Infectious Diseases
Association of Public Health Laboratories —Remote
- $86,600 - $100,700 a year
- Microsoft Excel
- Microsoft Outlook
- Computer literacy
12d
Vice President of Customer Growth
PatientIQ —Chicago, IL
- Full-time
- Remote
- Up to 50% travel
- Travel
- Senior level
- Dental insurance
- 401(k)
Quick Apply
Product Manager I, AIS
B. BRAUN MEDICAL (US) INC —Bethlehem, PA
- $95,000 - $115,000 a year
- Remote
- Hospital
- Pass drug screening
- Mid-level
- Health insurance
- 401(k)
Vice President, Product Design Quality
iRhythm Technologies, Inc. —San Francisco, CA
- $266,000 - $346,000 a year
- Full-time
- Remote
- 11+ years
- Product management
- Fair chance
Quick Apply
Clinical Sales Specialist, Vascular, St Louis or Kansas City MO
Teleflex —St. Louis, MO
- Remote
- Up to 50% travel
- Hospital
- Ability to walk for extended periods

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post market surveillance jobs near remote

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 remote

Manager- Post Market Surveillance (Recall)

Manager, Loss Prevention Training

Contract/Acquisition Specialist (Remote)

Statistical Analyst

Sr Quality Engineer - Post Market Data Analyst

Trade Surveillance Analyst 1 — Financial Crimes Department

Senior Medical Writer

Acquisition Specialist (Junior) Remote

Acquisition Management Support Subject Matter Expert (SME)

Senior Director, Post Market Monitoring

Clinical Product Surveillance Specialist

National - Regional Sales Manager - Caesars Entertainment (Remote)

Medical Safety Manager - EI

Sr Manager, Regulatory Affairs

Security Systems Designer - 100% Remote

Senior Specialist, Infectious Diseases

Vice President of Customer Growth

Product Manager I, AIS

Vice President, Product Design Quality

Clinical Sales Specialist, Vascular, St Louis or Kansas City MO

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