Regulatory Affairs Specialist Jobs in Waconia, MN

The Director of Regulatory Affairs in the quality control industry plays an essential role in ensuring that the company's products meet all regulatory standards and compliance requirements. This individual oversees the development and implementation of regulatory strategies for new and existing products, supervises the preparation of regulatory submissions, and maintains communication with regulatory authorities. They also monitor changes in regulations, interpret these updates for relevant departments within the company, and implement necessary changes to maintain compliance. They are responsible for setting the company's standards for quality, safety, and efficacy.

To excel in this role, one should possess excellent analytical skills, strategic thinking, and strong leadership abilities. A deep understanding of regulatory guidelines, ability to interpret complex regulations, and excellent communication skills are essential. They should have a degree in a relevant field, along with certifications such as Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA), and Certified Quality Engineer (CQE). Prior to becoming a Director of Regulatory Affairs, individuals might have roles such as Regulatory Affairs Specialist, Regulatory Affairs Manager, or Quality Control Manager.

1-9 of 9 Jobs

Senior Regulatory Affairs Specialist - Electrophysiology (on-site)

  • Plymouth, MN (19 miles from Waconia, MN)
  • 3 days ago
  • Plymouth, MN (19 miles from Waconia, MN)
  • 3 days ago

The Opportunity We are recruiting for a Senior Regulatory Affairs Specialist to join our team on-site in our St. Paul or Plymouth, MN locations....

Senior Regulatory Affairs Specialist - Electrophysiology (on-site)

  • Plymouth, MN (19 miles from Waconia, MN)
  • 13 hours ago
  • Plymouth, MN (19 miles from Waconia, MN)
  • 13 hours ago

Minnesota > Plymouth : 5050 Nathan Lane N ADDITIONAL LOCATIONS: United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL...

Regulatory Affairs Specialist III

  • Maple Grove, MN (22 miles from Waconia, MN)
  • 23 hours ago
  • Maple Grove, MN (22 miles from Waconia, MN)
  • 23 hours ago

We are looking to hire an enthusiastic individual for a Regulatory Affairs Specialist III position (hybrid work mode) supporting our rapidly growing Left Atrial Appendage Closure (LAAC) device portfolio...

Principal Regulatory Affairs Specialist

  • Maple Grove, MN (22 miles from Waconia, MN)
  • 3 days ago
  • Maple Grove, MN (22 miles from Waconia, MN)
  • 3 days ago

About the role: We are seeking a highly skilled and experienced Principal Regulatory Affairs Specialist to join our Peripheral Interventions Division....

Sr. Business System Compliance Analyst

  • Plymouth, MN (19 miles from Waconia, MN)
  • 7 days ago
  • Plymouth, MN (19 miles from Waconia, MN)
  • 7 days ago

Abbott Sr. Business System Compliance Analyst in Plymouth , Minnesota Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing...

Senior Regulatory Affairs Specialist (on-site)

  • Plymouth, MN (19 miles from Waconia, MN)
  • 28 days ago
  • Plymouth, MN (19 miles from Waconia, MN)
  • 28 days ago

The Opportunity Abbott is seeking a passionate, experienced Senior Regulatory Affairs Specialist to join our team on-site in Plymouth, MN....

Senior Regulatory Affairs Specialist

  • Plymouth, MN (19 miles from Waconia, MN)
  • 30+ days ago
  • Plymouth, MN (19 miles from Waconia, MN)
  • 30+ days ago

Specialized Knowledge: Knowledge of FDA Quality System regulations and ISO requirements. Knowledge of all applicable laws which regulate medical device manufacturers....

Compliance Analyst

  • Chanhassen, MN (10 miles from Waconia, MN)
  • 45+ days ago
  • Chanhassen, MN (10 miles from Waconia, MN)
  • 45+ days ago

Internal Audit Department Support: Support the Internal Audit team in other compliance-related tasks as needed....

Regulatory Affairs Specialist II Electrophysiology (on-site)

  • Plymouth, MN (19 miles from Waconia, MN)
  • 60+ days ago
  • Plymouth, MN (19 miles from Waconia, MN)
  • 60+ days ago

Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements...

Demographic Data for Waconia, MN

Moving to Waconia, MN? Find some basic demographic data about Waconia, MN below.


Local
National
14,552
418
Medium/Sm

Regulatory Affairs Specialist Online Courses and Training Opportunities

iHireQualityControl curates thousands of courses in order to recommend the best ones to help further your career. If you register for a course using the links on our site, we may receive a small commission.
Drug Regulatory Affair
OverviewDrug Regulatory Affairs (DRA) is a field that involves the study and implementation of regulations, guidelines, and laws related to the development, production, and marketing of...
Regulatory Affairs: CMC
This course provides an overview of the Chemistry, Manufacturing and Controls (CMC) section of dossiers and discusses CMC information necessary to support product applications, identifies CMC...
Regulatory affairs CTD course
Section 1-Regulatory affairs profesion -organization of different departments in pharmaceutical industry -Introduction to Common Technical Document (CTD)-Background on ICH guidance and CTD-Basic...

Salary for Regulatory Affairs Specialist Jobs in Waconia, MN

Estimated salary range based on data from US Bureau of Labor Statistics (BLS) and iHireQualityControl research efforts.

Licensing / Certification

Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.



Highest Education Level

Regulatory Affairs Specialists in Waconia, MN offer the following education background
Master's Degree
39.6%
Bachelor's Degree
39.5%
Doctorate Degree
8.6%
Associate's Degree
5.2%
Vocational Degree or Certification
3.3%
High School or GED
3.3%
Some College
0.5%

Average Work Experience
Here's a breakdown of the number of years' experience offered by Regulatory Affairs Specialists in Waconia, MN
2-4 years
55.0%
1-2 years
25.0%
4-6 years
10.0%
Less than 1 year
5.0%
None
5.0%



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