-
Regulatory Specialist
3 weeks ago
Planet Pharma Alameda, United StatesDuties: · Responsible for implementing and maintaining the effectiveness of the quality system. · Supports manufacturing/operations day to day activities for change control. · Provides consultation/advice to regulatory specialist for change control and product development. · Prov ...
-
Regulatory Specialist
2 weeks ago
GForce Life Sciences Alameda, United StatesRegulatory Affairs Specialist II On-site in Alameda, CAQualificationsBS in Life Sciences or Medical Engineering/Technology5+ years of professional experience (not internship experience)Medical device experience requiredNeeds to have the skill set and able to hit the ground runnin ...
-
Regulatory Specialist
2 weeks ago
GForce Life Sciences Alameda, United StatesRegulatory Affairs Specialist II – On-site in Alameda, CA · Qualifications · BS in Life Sciences or Medical Engineering/Technology · 5+ years of professional experience (not internship experience) · Medical device experience required · Needs to have the skill set and able to hit ...
-
Regulatory Specialist
5 days ago
Collabera Alameda, United StatesHome · Search Jobs · Job Description · Regulatory Specialist · Contract: Alameda, California, US · Salary: $53.00 Per Hour · Job Code: · End Date: · Days Left: 20 hours left · Apply · Position Details: · Industry: Medical Device · Job Title: Regulatory Specialist II · ...
-
Regulatory Specialist
3 weeks ago
Planet Pharma Alameda, United StatesDuties: · Responsible for implementing and maintaining the effectiveness of the quality system. · Supports manufacturing/operations day to day activities for change control. · Provides consultation/advice to regulatory specialist for change control and product development. · Prov ...
-
Regulatory Compliance Specialist
6 days ago
SPORTS RESEARCH CORPORATION San Pedro, United States**Company**:Sports Research · **Job Title**: Regulatory Compliance Specialist · **Location**: Corporate Office - 784 Channel Street, San Pedro, CA 90731 · **Hybrid Remote**:Work from home Thursdays · **Starting Rate**: $30.00 per hour · **About Us**: · - Sports Research is a lead ...
-
Regulatory Compliance Specialist
2 weeks ago
A-Line Staffing Solutions Alameda, United StatesA-Line Staffing Solutions is Hiring a Regulatory Compliance Specialist for a Managed Care Client in the Easy Bay - HYBRID - After training, the goal is for the position to be onsite 1 day per week, and 4 days per week remote Summary Under the directi Compliance Specialist, Regula ...
-
Regulatory Affairs Specialist
3 weeks ago
Synergy Solutions Hercules, United StatesEssential Onsite · - no hybrid. M-F 8:00 to 4:30 however we are flexible. · *Less than 1 year experience in IVD medical device industry is acceptable* · - Provide regulatory support for IVD products with multiple product groups within clinical diagnostics. · - Work with regulator ...
-
Regulatory Specialist II #:
3 weeks ago
HireTalent group Alameda, United States1 week ago Be among the first 25 applicants · Exempt/Non Exempt: Non Exempt Years Experience: 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function Skills: Knowledge of ...
-
Regulatory Specialist II #:
3 weeks ago
HireTalent group Alameda, United States1 week ago · Be among the first 25 applicants · Exempt/Non Exempt: Non Exempt Years Experience: 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function Skills: Knowledge o ...
-
Regulatory Compliance Specialist
1 week ago
Alinestaffing Alameda, United StatesA-Line Staffing Solutions is Hiring a Regulatory Compliance Specialist for a Managed Care Client in the Easy BayHYBRID* After training, the goal is for the position to be onsite 1 day per week, and 4 days per week remoteSummaryUnder the direction of the Manager, Regulatory Affair ...
-
Regulatory Specialist II
3 weeks ago
Spectraforce Technologies Alameda, United StatesJob Title: Regulatory Specialist II · Location: Alameda, CA · Duration: 12 Months · Shift: 8 AM to 5 PM · Experience Background (Any): Medical Device, Pharmaceutical, Regulatory Affairs, Quality Assurance, SW Engineering, APAC regulatory submission, or APAC-related work under Qu ...
-
Regulatory Specialist II
4 weeks ago
Spectraforce Alameda, United StatesJob Title: Regulatory Specialist II · Duration: 12 Months (Possibility of extension) · Location: Lake forest, IL · Open for remote · Shift: 8 am · 5 pm · Pay Rate Starts from $52/hr on W2 (Negotiable for the right candidate) · Summary: · The position of Regulatory Affairs Spe ...
-
Regulatory Compliance Specialist
1 week ago
Alinestaffing Alameda, United StatesA-Line Staffing Solutions is Hiring a Regulatory Compliance Specialist for a Managed Care Client in the Easy BayHYBRID* After training, the goal is for the position to be onsite 1 day per week, and 4 days per week remoteSummaryUnder the direction of the Manager, Regulatory Affair ...
-
Regulatory Affairs Specialist
2 days ago
Abbott Alameda, United StatesJob Description · Working at Abbott · At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to: · Career development with an international company where you can grow the career you d ...
-
Regulatory Affairs Specialist
3 days ago
Abbott Laboratories company Alameda, United StatesRegulatory Affairs Specialist – APAC - Diabetes Care (on-site) page is loaded · Regulatory Affairs Specialist – APAC - Diabetes Care (on-site) · Apply · locations · United States - California - Alameda · time type · Full time · posted on · Posted 3 Days Ago · job requisi ...
-
Regulatory Specialist II
9 hours ago
The Fountain Group Alameda, United StatesThe Fountain Group is a national staffing firm and we are currently seeking a Regulatory Specialist for a prominent client of ours. This position is located in Alameda, CA (onsite) · Details: · THIS POSITION IS 100% ONSITE · Pay for this position is 56.00 to 60.00 hourly dependi ...
-
Regulatory Specialist II
3 weeks ago
The Fountain Group Alameda, United StatesThe Fountain Group is a national staffing firm and we are currently seeking a Regulatory Specialist for a prominent clientof ours. This position is located in Alameda, CA (onsite) · Details: THIS POSITION IS 100% ONSITE · Pay for this position is 56.00 to 60.00 hourly depending ...
-
Regulatory Compliance Specialist
1 week ago
Alinestaffing Alameda, United StatesA-Line Staffing Solutions is Hiring a Regulatory Compliance Specialist for a Managed Care Client in the Easy Bay · HYBRID* After training, the goal is for the position to be onsite 1 day per week, and 4 days per week remote · Summary · Under the direction of the Manager, Regul ...
-
Regulatory Specialist II
2 weeks ago
Experis Alameda, United StatesExperis IT ManpowerGroup has partnered with a leading · Medical device · organization in the · Lake Forest, IL · for a · Associate Financial Analyst · role to assist their team. This is an on-site role. · Industry: · Medical device · Job Title : Regulatory Specialist II · ...
Regulatory Specialist II - Alameda, United States - Planet Pharma
Description
1-Year Contract$50-$55/Hour
Preferred:
Bilingual (Japanese or Chinese)
Duties:
Responsible for implementing and maintaining the effectiveness of the quality system.
Supports manufacturing/operations day to day activities for change control.
Provides consultation/advice to regulatory specialist for change control and product development.
Provides regulatory direction/interpretation on team activities.
Interprets and applies regulatory understanding to support of products and teams.
Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.
Handles regulatory activities involved in documentation, labeling, field support.
Applies regulatory and technical knowledge to a wide variety of complex work assignments.
Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.Job Description (Expectation)
Responsible for regulatory activities, including product registrations, impact assessment, etc.
Understand country-specific requirements and deliver those to internal stakeholders, including product management, engineering, labeling, etc., for product registration and change planning.
Communicate weekly with affiliate RAs in different time zones to catch up on ongoing projects and discuss the issues to solve.
Plan and execute the given tasks proactively in a timely manner.Report the status to a manager weekly.
Keep the training records up to date to do the tasks.
Other
Knowledge of International Standards, such as ISO13485, IEC60601.
Knowledge of APAC country regulations, such as TGA, NMPA, PMDA, MFDS, HSA, TFDA, FDA, MOH, etc.
Knowledge of Agile, SharePoint, MS Office, and other software to increase work efficiency.
Ability to manage time and projects.
Strict to work 40hrs per week.
Skills:
Knowledge of regulations and standards affecting IVDs and/or biologics
Education:
BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.
Job ID:
#J-18808-Ljbffr