Regulatory Affairs Specialist Department: Regulatory Reports To: Director of Regulatory Affairs ... Create and/or modify regulatory procedures to remain in compliance with FDA, ISO, European ...
Regulatory Affairs Specialist Department: Regulatory Reports To: Director of Regulatory Affairs ... Create and/or modify regulatory procedures to remain in compliance with FDA, ISO, European ...
Regulatory Affairs Specialist
Brecksville, OH · On-site
Regulatory Affairs Specialist Department: Regulatory Reports To: Director of Regulatory Affairs ... Create and/or modify regulatory procedures to remain in compliance with FDA, ISO, European ...
Regulatory Affairs Specialist
Brecksville, OH · On-site
Regulatory Affairs Specialist Department: Regulatory Reports To: Director of Regulatory Affairs ... Create and/or modify regulatory procedures to remain in compliance with FDA, ISO, European ...
Director, Regulatory Affairs, Ex-US
$151K - $199K/yr
Larimar is seeking a Director, Regulatory Affairs, to support the global regulatory strategy and drive regulatory activities for products in development specific to European and other global regions.
Director, Regulatory Affairs, Ex-US
$151K - $199K/yr
Larimar is seeking a Director, Regulatory Affairs, to support the global regulatory strategy and drive regulatory activities for products in development specific to European and other global regions.
Director, Regulatory Affairs, Ex-US
$143K - $189K/yr
Larimar is seeking a Director, Regulatory Affairs, to support the global regulatory strategy and drive regulatory activities for products in development specific to European and other global regions.
Director, Regulatory Affairs, Ex-US
$143K - $189K/yr
Larimar is seeking a Director, Regulatory Affairs, to support the global regulatory strategy and drive regulatory activities for products in development specific to European and other global regions.
European Notified Body, BSI, European MDR, and FDA). The Senior Regulatory Affairs Specialist helps to define data and information needed for regulatory actions in conjunction with cross-functional ...
European Notified Body, BSI, European MDR, and FDA). The Senior Regulatory Affairs Specialist helps to define data and information needed for regulatory actions in conjunction with cross-functional ...
Director, Regulatory Affairs, Ex-US
Philadelphia, PA · On-site
$151K - $199K/yr
Larimar is seeking a Director, Regulatory Affairs, to support the global regulatory strategy and drive regulatory activities for products in development specific to European and other global regions.
Director, Regulatory Affairs, Ex-US
Philadelphia, PA · On-site
$151K - $199K/yr
Larimar is seeking a Director, Regulatory Affairs, to support the global regulatory strategy and drive regulatory activities for products in development specific to European and other global regions.
Director, Regulatory Affairs, Ex-US
$143K - $189K/yr
Larimar is seeking a Director, Regulatory Affairs, to support the global regulatory strategy and drive regulatory activities for products in development specific to European and other global regions.
Quick apply
Director, Regulatory Affairs, Ex-US
$143K - $189K/yr
Larimar is seeking a Director, Regulatory Affairs, to support the global regulatory strategy and drive regulatory activities for products in development specific to European and other global regions.
European Notified Body, BSI, European MDR, and FDA). The Senior Regulatory Affairs Program Lead helps to define data and information needed for regulatory actions in conjunction with cross-functional ...
European Notified Body, BSI, European MDR, and FDA). The Senior Regulatory Affairs Program Lead helps to define data and information needed for regulatory actions in conjunction with cross-functional ...
European Notified Body, BSI, European MDR, and FDA). The Senior Regulatory Affairs Program Lead helps to define data and information needed for regulatory actions in conjunction with cross-functional ...
European Notified Body, BSI, European MDR, and FDA). The Senior Regulatory Affairs Program Lead helps to define data and information needed for regulatory actions in conjunction with cross-functional ...
Minimum 5 years direct experience in regulatory affairs (preferably in the medical device/drug or ... S. FDA and European Notified Bodies is required. -Experience presenting at FDA meetings is ...
Minimum 5 years direct experience in regulatory affairs (preferably in the medical device/drug or ... S. FDA and European Notified Bodies is required. -Experience presenting at FDA meetings is ...
Regulatory Affairs Specialist
Mansfield, MA · On-site
Regulatory Affairs Specialist Location: Mansfield, MA Duration: 5+ months (possibility of extension ... S. and European medical device regulations, and intimate knowledge of regulations regarding ...
Regulatory Affairs Specialist
Mansfield, MA · On-site
Regulatory Affairs Specialist Location: Mansfield, MA Duration: 5+ months (possibility of extension ... S. and European medical device regulations, and intimate knowledge of regulations regarding ...
Regulatory Affairs Manager
Plantation, FL · On-site
Minimum 5 years direct experience in regulatory affairs (preferably in the medical device/drug or ... S. FDA and European Notified Bodies is required. -Experience presenting at FDA meetings is ...
Regulatory Affairs Manager
Plantation, FL · On-site
Minimum 5 years direct experience in regulatory affairs (preferably in the medical device/drug or ... S. FDA and European Notified Bodies is required. -Experience presenting at FDA meetings is ...
European Notified Body, BSI, European MDR, and FDA). The Senior Regulatory Affairs Program Lead helps to define data and information needed for regulatory actions in conjunction with cross-functional ...
European Notified Body, BSI, European MDR, and FDA). The Senior Regulatory Affairs Program Lead helps to define data and information needed for regulatory actions in conjunction with cross-functional ...
Director, Regulatory Affairs, Ex-US (Philadelphia)
Philadelphia, PA · On-site
$143K - $189K/yr
Larimar is seeking a Director, Regulatory Affairs, to support the global regulatory strategy and drive regulatory activities for products in development specific to European and other global regions.
Director, Regulatory Affairs, Ex-US (Philadelphia)
Philadelphia, PA · On-site
$143K - $189K/yr
Larimar is seeking a Director, Regulatory Affairs, to support the global regulatory strategy and drive regulatory activities for products in development specific to European and other global regions.
Engage with European, Canadian provincial and US state and local agency officials to facilitate ... Manage the government affairs budget, including lobbying expenses, association memberships, and ...
Engage with European, Canadian provincial and US state and local agency officials to facilitate ... Manage the government affairs budget, including lobbying expenses, association memberships, and ...
Regulatory Affairs Coordinator
Salt Lake City, UT · Remote
$65K - $75K/yr
Regulatory Affairs Coordinator Bridor North America is expanding rapidly in the U ... S. market, bringing world-class, European-inspired baked goods to customers across retail ...
Quick apply
Regulatory Affairs Coordinator
Salt Lake City, UT · Remote
$65K - $75K/yr
Regulatory Affairs Coordinator Bridor North America is expanding rapidly in the U ... S. market, bringing world-class, European-inspired baked goods to customers across retail ...
Director, Medical Affairs
Foster City, CA · On-site
Contributes to the development of European and global medical POAs * Collaborates effectively and ... Stays up to date with Medical Affairs management approaches in the industry and applies them to the ...
Director, Medical Affairs
Foster City, CA · On-site
Contributes to the development of European and global medical POAs * Collaborates effectively and ... Stays up to date with Medical Affairs management approaches in the industry and applies them to the ...
Contributes to the development of European and global medical POAs * Collaborates effectively and ... Stays up to date with Medical Affairs management approaches in the industry and applies them to the ...
Contributes to the development of European and global medical POAs * Collaborates effectively and ... Stays up to date with Medical Affairs management approaches in the industry and applies them to the ...
Engage with European, Canadian provincial and US state and local agency officials to facilitate ... Manage the government affairs budget, including lobbying expenses, association memberships, and ...
Engage with European, Canadian provincial and US state and local agency officials to facilitate ... Manage the government affairs budget, including lobbying expenses, association memberships, and ...
Regulatory affairs with Technical Files, or equivalent in an R&D or quality position with hands-on ... Qualifications Must have knowledge of European/International and US regulations and standards;
Regulatory affairs with Technical Files, or equivalent in an R&D or quality position with hands-on ... Qualifications Must have knowledge of European/International and US regulations and standards;
European Affairs information
See salary details
$18.99 - $22.95
3% of jobs
$22.95 - $26.90
6% of jobs
$26.90 - $30.86
13% of jobs
$31.38 is the 25th percentile. Wages below this are outliers.
$30.86 - $34.81
20% of jobs
The median wage is $36.35 / hr.
$34.81 - $38.77
19% of jobs
$38.77 - $42.72
9% of jobs
$44.70 is the 75th percentile. Wages above this are outliers.
$42.72 - $46.68
10% of jobs
$46.68 - $50.63
6% of jobs
$50.63 - $54.59
5% of jobs
$54.59 - $58.54
5% of jobs
$58.54 - $62.50
3% of jobs
$18
$39
$62
How much do european affairs jobs pay per hour?
What are European Affairs professionals?
What are the key skills and qualifications needed to thrive in European Affairs, and why are they important?
What is the difference between European Affairs vs European Policy Analyst?
| Aspect | European Affairs | European Policy Analyst |
|---|---|---|
| Required Credentials | Degree in Political Science, International Relations, or Law | Degree in Political Science, International Relations, or Law |
| Work Environment | Government agencies, NGOs, EU institutions | Think tanks, research institutions, EU bodies |
| Employer & Industry Usage | Used broadly across organizations involved in European issues | Primarily in policy research and analysis roles |
European Affairs professionals focus on managing and coordinating issues related to Europe, often working within government or NGOs. European Policy Analysts primarily conduct research and analyze policies affecting Europe, typically within think tanks or research organizations. While both roles require similar credentials and work in related environments, European Affairs roles are more operational, whereas European Policy Analysts focus on in-depth policy analysis.
What are some common challenges faced by professionals working in European Affairs roles?
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- Entry Level Regulatory Affairs
Job description
Description
Job Title: Regulatory Affairs Specialist
Department: Regulatory
Reports To: Director of Regulatory Affairs
FLSA Status: Exempt
Supervise the work of others: No
Position Summary:
This position is responsible for preparing submissions to various regulatory agencies - most notably those pertaining to FDA 510(k) premarket notifications. Additionally the position will help maintain and improve upon engineering document control. Candidate must possess the ability to work well in a team environment and demonstrate great attention to detail.
Duties and Responsibilities:
This list is not comprehensive but meant to represent the most common or important duties of the position. Other duties may be assigned.
- Assist with the preparation and submission of regulatory filings, including FDA 510(k) premarket notifications and product listings.
- Create and/or modify regulatory procedures to remain in compliance with FDA, ISO, European, Canadian, and other standards.
- Work with the international department on various regulatory filings for product registration in different countries.
- Provides regulatory support for other projects as required.
- Updating appropriate personnel on new and revised processes and procedures.
- Process, execute, organize and archive various internal documentation related to Engineering and/or Quality Systems.
- Preparing change order documentation and routing it for final approval.
Requirements
Minimum Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience:
- Minimum of 2 year college degree, Bachelor's Degree (or greater) preferred.
- Relevant work experience, preferably in the medical or legal field and/or other regulated industry.
- Previous experience creating 510k's desirable.
- Knowledge of FDA and ISO 13485 regulations preferred.
- Knowledge of international regulatory guidelines regarding GMP requirements is desirable.
About Applied Medical Technology
Sourced by ZipRecruiter
Industry
Medical equipment and supplies manufacturing
Company size
51 - 200 Employees
Headquarters location
Brecksville, OH, US
Year founded
1985