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Regulatory Affairs Specialists
Collabera | Milwaukee, WI | 7/10/2014

Job Title: Regulatory Affairs Specialists

Job Location: Milwaukee, WI

Duration: 12 Months

Job Description


The Regulatory Affairs Leader provides subject matter expertise and works with a team of regulatory affairs professionals to ensure established best practice within the assigned area of responsibility (regional regulatory submissions & reporting, technical standards, collection and dissemination of intelligence, influencing the global regulatory environment, etc). 

Key responsibilities include:

  • Work closely with regulatory, engineering, marketing, legal, and other professionals across the company to develop & implement company-wide programs and processes for regulatory affairs compliance within areas of responsibility.
  • Identify regulatory trends and their implications for Healthcare; Develop & implement effective regulatory strategies to meet business objectives
  • Analyze & communicate proposed, new or changing requirements, & devise strategies for their implementation, ensuring business goals are met.
  • Scan the external environment and work with external associations to proactively adapt regulatory strategies and influence change within areas of responsibility.
  • Educate, train, & advise company professionals to ensure compliance with RA requirements.
  • Audit business units for compliance and consistency, and track/address trends observed that could lead to non-compliance, or risk to patient/user safety.
  • Collect, summarize & evaluate performance metrics to identify program weaknesses & drive improvements in procedures or oversight.
  • Support continuous improvement activities with regard to areas of responsibility.
Drive improvements to overall Quality Management System documentation to provide clear flow down of regulations in areas of responsibility


Required Skills: Regulatory Affairs


Ankur Desai


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Employment Type: Full-Time
Base Pay: N/A
Other Pay: N/A
Industry: Industrial
Education: Not Specified
Experience: Not Specified
Manages Others: Not Specified
Relocation: Not Specified
Required Travel: Not Specified
Job ID: 2389_Regulatory_Affairs

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At Collabera, you get a chance to do great work with some of the brightest people, without the frustration of being a nameless face in a sea of cubicles. We promote a culture of transparency and openness that embraces enthusiasm and passion. If you have what it takes, we want you to follow your passion.

Whether that means working on cutting edge technology, understanding and overcoming business challenges, becoming a cross-discipline general practitioner or something else entirely. Passion and interesting work brings people to Collabera. Teamwork, growth and exposure keep people here as they build a career. Learn More...

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