Senior Regulatory Affairs Specialist Job at Intellectt Inc, Lake Forest, CA

UzhWTmo0L0hzOERtNU9lVDZrZ1VvMmhmY2c9PQ==
  • Intellectt Inc
  • Lake Forest, CA

Job Description

Role: Senior Regulatory Affairs Specialist

Location: Lake Forest, IL - 60045

Duration: 08 Months

Description:

Years Experience: Must have 3-5 years of experiences in Medical Device Regulatory Affairs

Duties:

  • This position will be working with multiple business units to develop, update, and improve regulatory affair processes.
  • Assist the strategy implementation and operations for regulatory affairs activities, including directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
  • Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR.
  • Identify opportunity for regulatory affair processes and drive changes to completion. "

Skills:

  • Have working knowledge in EU MDR
  • Have working knowledge in Regulatory Change Assessment in
  • Have working knowledge in US and EU medical device submissions
  • Have experience supporting internal and external inspections
  • Work cross-functionally and in a matrixed environment
  • Have experience with continuous improvement activities

Job Tags

Similar Jobs

Cardinal Health

Warehouse Associate - Flex Night Shift Job at Cardinal Health

 ...Qualifications_**_We are open to candidates with little to no warehouse experience. If you are comfortable working in a fast-paced, goal-oriented...  ...in the facility includes order picker (cherry picker), forklift, reach truck, turret truck, pallet jack, and walkie rider_... 

Bath Concepts Independent Dealers

Call Center Manager Job at Bath Concepts Independent Dealers

 ...Confirmation Call Center Manager Location: San Diego, CA Creating a fresh solution to bath remodeling, California Bathrooms, Inc. offers stylish, cost-effective, low-maintenance bath improvements for homeowners, commercial customers, and consumers with accessibility... 

NDCP

Selector Job at NDCP

 ...seeking passionate individuals to join our dynamic team as Selector We are a $3 billion global supply chain management company serving Dunkin franchisees. We support over 10,000 quick service restaurants in the U.S. and distribute products to more than 40 countries.... 

Tiffany & Co.

MBA Intern - Demand Planning Job at Tiffany & Co.

Tiffany & Co. is seeking an MBA Intern for its Demand Planning team in New York. The role involves driving sales planning analyses and leading innovative projects to support critical launches and product categories. Candidates should have strong analytical skills, proficiency... 

Samtec

Quality Manager - Cable Manufacturing Job at Samtec

 ...product portfolio includes High-Speed Board-to-Board, High-Speed Cables, Optics for Mid-Board and Panel, Precision RF, Flexible Stacking...  ...customer audits, and collect and summarize customer quality data to drive improvement. \n Direct Manufacturing Quality Engineering...