Senior Regulatory Affairs Specialist The Opportunity This position works out of our
Itasca or Chicago, IL (Willis Towers) location in the
Abbott Molecular Division. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.
As an individual contributor, the function of a
Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. This role is part of the on-market regulatory team and includes responsibility for performing regulatory impact assessments for changes related to marketed products. The individual may assist in identifying data needed, obtaining data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.
What You'll Work On - Interpret and apply regulatory requirements.
- Perform regulatory impact assessments to evaluate changes for on-market products.
- Compile, prepare, review, and submit regulatory submissions to authorities.
- Regulatory history, guidelines, policies, standards, practices, requirements, and precedents.
- Regulatory agency structure, processes, and key personnel.
- Principles and requirements of applicable product laws.
- Submission/registration types and requirements.
- Principles and requirements of promotion, advertising, and labeling.
- Domestic and international regulatory guidelines, policies, and regulations.
- Ethical guidelines of the regulatory profession, clinical research, and regulatory process.
Required Qualifications- Bachelor's degree (or equivalent); bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
- Regulatory experience or relevant industrial experience typically with a quality; product development/ support, scientific affairs function.
Preferred Qualifications- Two to Three years of experience in regulatory preferred.
- Three to four years' experience in a regulated industry (e.g., medical products, nutrition
- Masters degree in Regulatory Affairs may be used in lieu of direct regulatory experience.
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
The base pay for this position is
$78,000.00 - $156,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Regulatory Operations
DIVISION:AMD Molecular
LOCATION:United States > Itasca - AMDC : 1015 West Devon Ave
ADDITIONAL LOCATIONS:United States > Chicago : Willis Tower Building 233 S Wacker Dr.
WORK SHIFT:Standard
TRAVEL:Yes, 5 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
