5 Jobs in Bedford, MA
Genabio Diagnostics Inc. is Hiring a Regulatory Affairs Manager Near Bedford, MA
Qualifications:
· Bachelor's degree or above in a relevant discipline required
· 5 years of industrial experience in IVD or medical device FDA registration
· Proficiency in Chinese preferred
Tasks:
· Lead and support new product 510k Submissions
· Lead and support International Device Licensing and Registrations
· Support product development teams with new product submission requirements
· Provide guidance on worldwide regulatory requirements for medical devices and external government product audits by FDA and other inspection agencies as needed
· Lead and support the implementation of clinical research projects
· Develop and support clinical sites management through all phases of the clinical trial
· Travel to clinical sites during the qualification phase and as needed to ensure sites are in compliance and regulatory and study requirements are being fulfilled
· Ensure that documentation from clinical trial sites meets FDA/GCP/GDP requirements
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Experience level:
- 5 years
Experience:
- FDA regulations: 5 years (Preferred)
Ability to Commute:
- Bedford, MA 01730 (Required)
Ability to Relocate:
- Bedford, MA 01730: Relocate before starting work (Required)
Work Location: In person
Job Summary
Full Time
$106k-138k (estimate)
05/12/2024
09/07/2024
The job skills required for Regulatory Affairs Manager include Clinical Trial, Clinical Research, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Affairs Manager. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory Affairs Manager. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Regulatory Affairs Manager positions, which can be used as a reference in future career path planning. As a Regulatory Affairs Manager, it can be promoted into senior positions as a Regulatory Affairs Senior Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Affairs Manager. You can explore the career advancement for a Regulatory Affairs Manager below and select your interested title to get hiring information.
If you are interested in becoming a Regulatory Affairs Manager, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Regulatory Affairs Manager for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Regulatory Affairs Manager job description and responsibilities
Regulatory Affairs Managers plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
04/15/2022: Charleston, SC
They will provide responses to regulatory agencies regarding product information or issues.
04/10/2022: Charleston, SC
They'll establish regulatory priorities or budgets and allocate resources and workloads.
02/22/2022: Temple, TX
Ensures sponsored studies are disclosed according to applicable laws, regulatory requirements and policies.
02/15/2022: Harlingen, TX
The position will provide regulatory review, registration and data management, strategic regulatory advice and submissions to appropriate regulatory agencies.
05/09/2022: New Brunswick, NJ
Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Regulatory Affairs Manager jobs
Having the knowledge and understanding of complex medical and scientific subject matter would give you advantage for this role.
03/10/2022: Springfield, OR
You need the ability to build networks to obtain cooperation.
03/12/2022: Temple, TX
Manager Regulatory Affairs are able to balance projects with day-to-day duties, ensuring participation from other members of the department as needed.
04/10/2022: Great Falls, MT
They utilize their technical skills to ensure products remain safe and efficient by meeting all the regulatory standards.
03/28/2022: Lowell, MA
You need to have IT skills, particularly in relation to using databases and familiarity with commercial software to qualify for this role.
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Step 3: View the best colleges and universities for Regulatory Affairs Manager.
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