Senior Regulatory Quality Specialist â Medical Devices (on-site)
Senior Regulatory Quality Specialist â Medical Devices (on-site)
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 75300 - 150700
1 Vacancy
Job Description
JOB DESCRIPTION:
Working at Abbott
At Abbott you can do work that matters grow and learn care for yourself and family be your true self and live a full life. Youll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors degree.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity working mothers female executives and scientists.
For years Abbotts medical device businesses have offered technologies that are faster more effective and less invasive. Whether its glucose monitoring system innovative therapies for treating heart disease or products that help people with chronic pain or movement disorders our medical device technologies are designed to help people live their lives better and healthier. Every day our technologies help more than 10000 people have healthier hearts improve quality of life for thousands of people living with chronic pain and movement disorders and liberate more than 500000 people with diabetes from routine ngersticks.
The Opportunity
We are looking for our next Senior Regulatory Quality Specialist to join our team on-site out of our Maple Grove or St. Paul MN locations. This Regulatory Quality Senior Specialist position would be structured under the Global Regulatory Services (GRS) function managing projects related to harmonized regulatory activities in the Abbotts medical device division. As an individual contributor the function of a RA QA Specialist is to combine the knowledge of Regulatory Quality and Compliance to lead and assist implementation projects for emerging regulations and supporting quality compliance related activities for the GRS department. With limited supervision coordinates and compiles regulatory procedures/processes and leads Regulatory systems projects to assure business needs are met and optimized for efficiency and effectiveness. Communicate with business partners to author and implement regulatory procedural changes. Support ongoing RA Operation system implementations and process improvements.
What Youll Work On
- Lead procedural updates and emerging regulation implementation working with cross BU/ cross functional teams
- Develop new regulatory policies processes and SOPs
- Facilitate procedure implementation
- Provide strategic input and technical guidance on regulatory requirements for process decisions
- Evaluate regulatory risks of division policies processes procedures
- Drive change order activities
- Create supplemental training materials
- Review and follow document quality system structure
- Lead team meetings and document meeting minutes
- Analyzes quality reports and metrics from tracking tools; identifies trends and ramifications
- Work on process workflow development teams collaborating with Abbott IT system enhancement teams
Required Qualifications
- Bachelors degree or an equivalent combination of education and work experience
- Minimum 3 years experience in a regulated industry (e.g. medical products nutritionals). 2-3 years of experience in regulatory preferred but may consider quality assurance research and development/support scientific affairs operations or related area.
- Experience with submission/registration types and requirements.
- Write and edit technical documents.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills as well as attention to detail.
Preferred Qualifications
- Masters Degree in Regulatory Affairs and may be used in lieu of direct regulatory experience.
- 5 years experience in a regulated industry
- Knowledge of Regulations
- Familiarity with Regulatory Affairs departmental responsibilities and processes
- CAPA experience
- Windchill experience
- Procedural Writing
- Regulatory Change Assessment
- International Product Registration support
- Ad and Promotional Material - Regulatory Review
- EU and US medical device compliance
- Project management skills organize and host meetings
- Quality System maintenance activities
- Documenting justification for change from Regulatory perspective
- Regulatory history guidelines policies standards practices requirements and precedents
- GDP
- Experience working in the Medical Device industry.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.
Connect with us at on Facebook at and on Twitter @AbbottNews.
The base pay for this position is
$75300.00 $150700.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
MD Medical Devices
LOCATION:
United States > Maple Grove : 6820 Wedgwood Road N.
ADDITIONAL LOCATIONS:
United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza
WORK SHIFT:
Standard
TRAVEL:
Yes 5 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive (arms above shoulder bent wrists) Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: EEO is the Law link - Espanol: Experience:
Senior IC
Employment Type
Full-Time
Key Skills
Similar Jobs
Dr. Job is an online platform that connects employers with skilled job seekers, facilitating the search for job opportunities and top talent. Established in 2015. Dr. Job Pro has emerged as the world premier job portal, attracting thousands of job seekers every day from all over the world.
Follow Dr.Job
Dr Job FZ LLC. 2025 © All Rights Reserved