Regulatory Affairs Specialist I

Profile

**MEMBERS ONLY**SIGN UP NOW***. is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
**MEMBERS ONLY**SIGN UP NOW***.’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on
**MEMBERS ONLY**SIGN UP NOW***.’s diagnostics instruments, providing lab results for millions of people.
The position of Regulatory Affairs Specialist I
is within our Infectious Disease Developed Markets business unit.  In this role you will with general guidance, perform a variety of functions in support of domestic and international product registrations for new and modified products. 
This position will focus on
post-market Regulatory Reporting only.
WHAT YOU’LL DO
Post-market Regulatory Reporting/Complaint Handling
Processes Reportability Determinations
Prepares and Submits Regulatory Reports for FDA and other OUS (Outside of US) Regulatory Bodies
Monitors  progress of all ongoing complaint activities and MDRs to ensure the timely submissions
Assists in the preparation of regulatory body additional information requests.
Organizes and maintains hard copy and electronic department files.
Keeps informed of global regulatory information.
Assists in developing internal procedures and tools.
Carries out duties in compliance with established business policies.
Demonstrates commitment to the development, implementation and effectiveness of **MEMBERS ONLY**SIGN UP NOW***. 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.
EDUCATION AND EXPERIENCE YOU’LL BRING
Required
Bachelor’s Degree in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience.
COMPETENCIES:
Knowledge of Federal 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
Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio
WHAT WE OFFER
At **MEMBERS ONLY**SIGN UP NOW***., you can have a good job that can grow into a great career. We offer:
Training and career development
, with onboarding programs for new employees and tuition assistance
Financial security
through competitive compensation, incentives and retirement plans
Health care and well-being programs
including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k)
retirement savings with a generous company match
The stability of a company
with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: 
****Follow your career aspirations to **MEMBERS ONLY**SIGN UP NOW***. for diverse opportunities with a company that provides the growth and strength to build your future. **MEMBERS ONLY**SIGN UP NOW***. is an
Equal Opportunity Employer, committed to employee diversity.
Connect with us at ****, on Facebook at
****and on Twitter @**MEMBERS ONLY**SIGN UP NOW***.News and @**MEMBERS ONLY**SIGN UP NOW***.Global.
,industry:Healthcare,title:Regulatory Affairs Specialist IDivision: IDDM ARDx Infectious Disease Developed Markets
Additional Location: United States - Illinois - Waukegan
Travel: No
Medical Surveillance: Not Applicable
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Categories
Healthcare
Biotechnology / Science
Engineering
Posted:
2022-02-23
Expires:
2022-03-25
**MEMBERS ONLY**SIGN UP NOW***.

Company info

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