Urgent! GEHC - Regulatory Affairs Specialists III Job Opening In Beachwood – Now Hiring Abacus Service Corporation
Description:
Manager's Note- Candidates must be in the Cleveland area, local to Cleveland, OH because they may have to come into office at 25800 Science Park Dr #180, Beachwood, OH 44122.
Title Regulatory Affairs Specialist
Number of Leased Workers needed 1
Tentative start date asap
Tentative end date 12 Months
Work shift (days/times) 1st Shift
Work Location 25800 Science Park Dr #180, Beachwood, OH 44122, three days per week expected to be in office so local candidates only should be submitted.
Travel Required (% of travel) No
Is this a temp to perm position pure contract
Regulatory Affairs
Job Description
Essential Responsibilities:
Provides regulatory input for product development to ensure compliance to regulatory requirements for target markets.
Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory requirements (including product testing, clinical data, etc.), product claims and country regulatory dependencies to ensure optimized sequencing for submissions.
Works with a cross functional team to prepare and submit regulatory submissions such as 510(k)s, MDR EU Technical Files, or submissions to other global regulators such as NMPA, TGA, etc., for the purpose of obtaining authorization for market launch.
Assesses changes in existing products to and determines the need for new / revised licenses or registrations.
Develops plan for timely submission of renewal registrations for applicable countries per business plan, to ensure continued product supply in those countries.
Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
Contributes to writing and editing technical documents.
Researches, analyzes, integrates, and organizes background information from diverse sources for regulatory submissions.
Ensures compliance with pre- and post-market product approval requirements
Supports regulatory inspections, as required.
Qualifications/Requirements:
Bachelor's degree from an accredited university or college, preferred in a Scientific, Engineering, Regulatory, Legal, or core Life Science discipline.
4+ years' experience in a highly regulated industry, preferred in Regulatory Affairs, or equivalent experience through advanced degree or other relevant education and experience.
Strong verbal and written communication, and presentation skills, with the ability to speak and write clearly and convincingly in English.
Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and collaboration applications.
Desired Characteristics:
Demonstrated ability to analyze and resolve problems.
Ability to document, plan, market, and execute programs.
Established project management skills.
A team player and collaborator.
Preferably, Regulatory Affairs Certification (RAC) issued by the Regulatory Affairs Professionals Society (RAPS).
Experience in medical device regulatory affairs
Demonstrated life-long learner; eagerness to obtain new skills and knowledge.
| Enable Skills-Based Hiring | No |
| Qualification | Assessment |
|---|---|
| Must Have | |
| Healthcare | |
| Driving record verification? | No |
| Education verification? | No |
| GEHC Magnetic Resonance Employee Questionnaire for Metallic Foreign Body and Electronic Devices? | No |
| Yes | ||
|---|---|---|---|
| Yes |
| Hours per Day | 8 |
|---|---|
| Hours per Week | 40 |
| Total Hours | 2,080.00 |
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Unlock Your GEHC Regulatory Potential: Insight & Career Growth Guide
Real-time GEHC Regulatory Jobs Trends in Beachwood, United States (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for GEHC Regulatory in Beachwood, United States using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 3227 jobs in United States and 8 jobs in Beachwood. This comprehensive analysis highlights market share and opportunities for professionals in GEHC Regulatory roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! Abacus Service Corporation is currently hiring and seeking a GEHC Regulatory Affairs Specialists III to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: GEHC Regulatory Affairs Specialists III Jobs Beachwood.
An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Abacus Service Corporation adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a GEHC Regulatory Affairs Specialists III Jobs United States varies, but the pay scale is rated "Standard" in Beachwood. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for GEHC Regulatory Affairs Specialists III typically include Business Operations Specialists and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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