Top 41249 Manager regulatory documents Jobs

Regulatory Affairs Specialist II (Need IVDD / IVDR and/or strong EU MDR experience)
Entegee —Orange County, CA
- $45 - $50 an hour
- Full-time
- Hybrid work
- Mid-level
- 3 years
- Bachelor's degree
- Commuter assistance
- Disability insurance
Quick Apply
Product Manager- Absence & Disability - Remote
USAble Life —Little Rock, AR
- $81,000 - $120,000 a year
- Remote
- Mid-level
- 3 years
- Analysis skills
- Paid holidays
- Tuition reimbursement
Senior Manager, Regulatory Compliance
Behavioral Health Systems, Inc. —Birmingham, AL
- $120,000 - $150,000 a year
- Full-time
- Hybrid work
- 5 years
- Case management
- Travel
- Health insurance
- Dental insurance
Quick Apply
SH&E Manager (Remote)
Parsons —Remote
- $112,200 - $196,400 a year
- Remote
- Databases
- 8 years
- Bachelor's degree
- Wellness program
- Paid holidays
11d
Sr. Manager, Regulatory Affairs
Vaxcyte —Remote
- $183,000 - $194,000 a year
- Remote
- Bachelor of Science
- Bachelor's degree
- Computer skills
Manager, Regulatory Affairs
Jade Biosciences —Seattle, WA
- $135,000 - $150,000 a year
- Remote
- Microsoft Word
- 3 years
- Bachelor's degree
Quick Apply
Subcontract Program Manager
Parsons —Remote
- $148,300 - $266,900 a year
- Remote
- Engineering
- 11+ years
- English
- Wellness program
- Paid holidays
Senior Program Manager - Must Reside in KY (Regulatory/Legal Experience Preferred)
Molina Healthcare —Kentucky
- $69,447.00 - $142,548.59 a year
- Full-time
- 7 years
- Master's degree
- Bachelor's degree
- Health insurance
Quality Operations Program Manager - Document Control
Veeva Systems —Remote
- $100,000 - $150,000 a year
- Full-time
- Remote
- 5 years
- Bachelor of Science
- Bachelor's degree
- Paid holidays
- Health insurance
Clinical Nurse Manager - Maternal Newborn - Children's Hospital
University of Missouri Health Care —Columbia, MO
- $108,971 - $177,590 a year
- Full-time
- Nursing
- RN License
- Bachelor of Science
- Paid holidays
- Health insurance
Pharmacist
PharMerica —Asheville, NC
- Full-time
- Mid-level
- Bachelor's degree
- Leadership
- Health insurance
- Dental insurance
Full-time Senior Architect/Project Manager
Design Group Collaborative —Ellsworth, ME
- Full-time
- Office
- Residential
- Microsoft Office
- Health insurance
- 401(k)
Quick Apply
Civil Engineer Manager (General)
Commonwealth of PA —Emporium, PA
- $84,264 - $119,844 a year
- Full-time
- Driver's License
- 1 year
- Senior level
- Paid parental leave
- Health insurance
13d
Document Controller
Space Information Laboratories —Santa Maria, CA
- $25.88 - $43.84 an hour
- Full-time
- Background check
- Engineering
- Pass drug screening
- Disability insurance
- Health insurance
Quick Apply
13d
Quality Manager - 503b cGMP Environment
Wedgewood Pharmacy —Athens, OH
- From $110,000 a year
- Full-time
- 7 years
- Bachelor's degree
- Senior level
- Disability insurance
- Health insurance
Quick Apply
Quality Manager - 503b cGMP Environment
Wedgewood Pharmacy —Albany, OH
- From $110,000 a year
- Full-time
- 7 years
- Bachelor's degree
- Senior level
- Disability insurance
- Health insurance
Quick Apply
Home Health and Hospice Clinical Manager
BETHESDA HEALTH AND HOUSING —Willmar, MN
- $74,719.54 - $84,146.34 a year
- Weekends as needed
- CPR Certification
- Nursing
- RN License
Quick Apply
Production Manager - 3rd Shift
Norwich Pharmaceuticals Inc —Norwich, NY
- $85,000 - $95,000 a year
- Full-time
- Bachelor of Science
- Employment & labor law
- 3 years
- Wellness program
- Health savings account
Quick Apply
Project Manager Indiana
cGMPnow —Indianapolis, IN
- $150,000 - $200,000 a year
- Full-time
- Hybrid work
- Microsoft Outlook
- Construction site
- Customer service
- Profit sharing
- Paid training
Residential and Light Commercial Department Manager, Adobe Experience Required
Rainwater Management Solutions —Roanoke, VA
- $52,000 - $62,000 a year
- Full-time
- Background check
- Microsoft Outlook
- System design
- Health insurance
- Dental insurance
Quick Apply
5d

I want to receive the latest job alert for manager regulatory documents

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

manager regulatory documents jobs near

Regulatory Affairs Specialist II (Need IVDD / IVDR and/or strong EU MDR experience)

Entegee -
Orange County, CA

Quick Apply

Job Details

Full-time | Contract
$45 - $50 an hour

Benefits

Commuter assistance
Disability insurance
Health insurance
Dental insurance
Vision insurance
Life insurance

Qualifications

Biology
Biochemistry
Technical documentation
Bachelor's degree
Manufacturing

Full Job Description

Hybrid position for a top Biotech company in Irvine, CA. 3 days a week onsite (core days are Tues/Thurs with 3rd onsite day a choice).

** If candidates don't have IVD industry experience, open to candidates with strong EU MDR submission experience! **

** Regulatory Affairs Specialist II with working knowledge of FDA, and CE marking requirements for IVD products. Company is currently transitioning from IVDD to IVDR (In-Vitro Diagnostic Regulation).

** The Regulatory Affairs Specialist is responsible for the preparation & revision of IVD technical files when needed, updating labeling to comply with IVDR requirements, and tracking RA Regional notifications.

How You'll Make An Impact:

Support the IVDR project by revising the assigned technical files. Each technical file must be generated using the latest technical file template and it must clearly present the product, its characteristics and its expected performance to easily and fully understand the evidence of conformity. Each technical file must include the latest version of the required technical reports, validations, test reports and other documents listed in the technical file table of contents which are an integral part of the technical file. Each assigned technical file must be completed within a pre-defined timeline. Must attend multiple weekly meetings which are intended to help address issues or questions regarding the technical files and keep the project manager informed on the progress of the work.
Support the IVDR labeling conversion project which requires cross-functional participation and weekly group meetings to follow the conversion plan. Update the labeling conversion tracking log based on the monthly manufacturing schedule, the product fill dates, the associated product lot numbers and change requests numbers. As needed, update labeling specifications to meet the IVDR requirements.
Support the tasks to un-CE Mark selected products and track the work until the final labeling reflects the desired changes based on the labeling specification document.
Other miscellaneous activities will include updating the technical file tracking log, notifying and tracking RA Regional notifications of labeling changes, and notifying the RA SAP restriction coordinator when specific product lots need to be restricted to prevent distribution of the product in specific areas of the world.

What You Bring:

Requires a Bachelor's degree in biochemistry, biology, medical technology or related fields.
3-5 years of experience in RA, and/or QA, R&D, Manufacturing or Project Management in the IVD industry.
Knowledge of FDA, and CE marking requirements for IVD products is a plus.

Job Disclaimer:

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records.

#GRPA

Pay: $45.00 - $50.00 per hour

People with a criminal record are encouraged to apply

Work Location: Hybrid remote in Orange County, CA

Quick Apply

Refine Your Search

manager regulatory documents jobs

Regulatory Affairs Specialist II (Need IVDD / IVDR and/or strong EU MDR experience)

Product Manager- Absence & Disability - Remote

Senior Manager, Regulatory Compliance

SH&E Manager (Remote)

Sr. Manager, Regulatory Affairs

Manager, Regulatory Affairs

Subcontract Program Manager

Senior Program Manager - Must Reside in KY (Regulatory/Legal Experience Preferred)

Quality Operations Program Manager - Document Control

Clinical Nurse Manager - Maternal Newborn - Children's Hospital

Pharmacist

Full-time Senior Architect/Project Manager

Civil Engineer Manager (General)

Document Controller

Quality Manager - 503b cGMP Environment

Quality Manager - 503b cGMP Environment

Home Health and Hospice Clinical Manager

Production Manager - 3rd Shift

Project Manager Indiana

Residential and Light Commercial Department Manager, Adobe Experience Required

I want to receive the latest job alert for manager regulatory documents

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected