7 Regulatory specialist Jobs in Scarborough, ME
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TalentBurst is Hiring a Regulatory specialist Near Scarborough, ME
Title : Regulatory Affairs Specialist II
Location Scarborough Maine
Duration 6 months
The position of Regulatory Affairs Specialist II is within our Infectious Disease business
unit. In this role you will prepare documentation for EU Technical Files and international
product registrations.
This job description will be reviewed periodically and is subject to change by management.
RESPONSIBILITIES :
Responsible for technical writing of files in accordance with In Vitro Diagnostic medical
device Regulation (IVDR).
Provides regulatory support for diagnostic product development and commercial
diagnostic products.
Develops regulatory strategies for products in development and for modified products to
achieve clearance / approval in the EU and internationally.
Provides regulatory support to regional regulatory teams to assist with submissions,
license renewals, and license amendments.
Researches and communicates scientific and regulatory information in order to write
submission documents.
Compiles and publishes all material required for submissions, license renewals, and
annual registrations.
Maintains approvals / licenses / authorizations for existing marketing authorizations.
and compliance to regulations.
Develops internal procedures and tools.
Conducts informational or training sessions for stakeholders.
Organizes and maintains hard copy and electronic department files.
Demonstrates commitment to the development, implementation and effectiveness of
Client Quality Management System per ISO, FDA, and other regulatory agencies.
Responsible for exhibiting professional behavior with both internal / external business
associates that reflects positively on the company and is consistent with the company's
policies and practices.
BASIC QUALIFICATIONS EDUCATION :
Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering or other related
technical field or the equivalent combination of education and experience.
4 years' experience in Regulatory Affairs role.
Strong knowledge of IVDR and EU regulatory requirements is required.
PREFERRED QUALIFICATIONS :
1 years' experience in an IVD or medical device manufacturing environment.
COMPETENCIES :
Good knowledge of EU and international regulations.
Demonstrated written and verbal communication skills.
Strong time management skills, with the ability to work on multiple projects
simultaneously.
Ability to work independently as well as within a team.
Proficiency with Microsoft Office, including Word, Excel, PowerPoint and Visio
Last updated : 2024-04-27
Job Summary
Full Time
$63k-83k (estimate)
04/28/2024
05/06/2024
www.talentburst.com
Framingham, Massachusetts
1,000 - 3,000
Tom Murray
<$5M
Related Companies
About TalentBurst
TalentBurst, Inc. provides staffing and consulting, high hazard payroll, and managed service provider/VMS partner solutions to Fortune 1000 corporations. The company offers its staffing solutions in the areas of contract information technology, engineering, SaaS, bio-pharma, accounting and finance, marketing, utility, compliance, banking, biotechnology, healthcare, energy, government, retail, PMO, Web and infrastructure, database/data-warehousing, quality assurance, clinical, and other areas. It also provides services in the areas of health benefits, workers' compensation claims, payroll, payr...oll tax compliance, and unemployment insurance claims. The company serves customers in the United States, Canada, the United Kingdom, India, Chile, and Singapore. TalentBurst, Inc. was founded in 2002 and is based in Natick, Massachusetts. The company has branch locations in Boston, San Francisco, Miami, and Milwaukee; and international offices in Toronto, Canada; and Gurgaon and Bangalore, India. TalentBurst is a managed services provider (MSP).
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The job skills required for Regulatory specialist include Regulatory Affairs, ISO, Product Development, Microsoft Office, Chemistry, Verbal Communication, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Regulatory specialist positions, which can be used as a reference in future career path planning. As a Regulatory specialist, it can be promoted into senior positions as a Regulatory Affairs Specialist II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory specialist. You can explore the career advancement for a Regulatory specialist below and select your interested title to get hiring information.
If you are interested in becoming a Regulatory Specialist, 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 Specialist for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Regulatory Specialist job description and responsibilities
The regulatory specialist creates and maintains regulations for testing processes, the development phase, how production operates and the marketing and distribution for new products.
04/06/2022: Wilmington, NC
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
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Certified regulatory affairs specialists typically collect and review marketing, legal, regulatory and licensing documentation, case files, studies, reports, etc.
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Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
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works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products.
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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 Specialist jobs
Entry-level regulatory affairs professionals must have a bachelor’s degree.
02/23/2022: Chico, CA
Successful regulatory specialists are excellent writers, as they must write details and accurate reports for the evaluations they perform.
02/24/2022: Newport News, VA
Earn Regulatory Affairs Professionals Society certifications.
03/14/2022: Saint Paul, MN
On successful completion of the program, graduates can take up roles such as regulatory affairs specialists.
03/19/2022: Ann Arbor, MI
At conferences and forums, specialists develop their existing knowledge and learn about emerging regulations, standards, and guidance documents.
04/28/2022: Lowell, MA
Step 3: View the best colleges and universities for Regulatory Specialist.
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