Regulatory Affairs Specialist

CTG Indianola , PA 15051

Posted 1 week ago

CTG Inc. has been a highly respected provider of contract personnel throughout the United States for more than fifty years.

Currently, our valued client in Indianola, PA has an opening for a Regulatory Affairs Specialists. This position is a 6-month contract, with the potential for continuation after the initial contract.

Description:

POSITION/TITLE: Regulatory Affairs Specialist

DESCRIPTION

The Regulatory Affairs department provides regulatory support for Radiology devices by ensuring compliance with local and international regulations.

POSITION SUMMARY

The primary purpose of this role is to develop regulatory assessments and strategies in support of product design changes and product line extensions as well as maintaining regulatory certification documentation for US, EU, and Canada.

POSITION DUTIES & RESPONSIBILITIES

Maintain Regulatory Documentation

  • Updates Technical Files needed for CE marking to reflect requirements of new regulations and compliance with Bayer policies in procedures

  • Evaluates regulatory impact of product changes for US, Canada, and EU. Documents and communicates assessment to product development teams.

  • Ensures regulatory compliance in US, Canada, and EU by properly documenting product, labeling and quality-related changes in regulatory filings

  • Coordinates assessment of international regulatory impact of product design and labeling changes by interfacing with International Regulatory Affairs team representatives

Support Compliance Efforts

  • Drafts/edits corporate policies and procedures to reflect new regulations

  • Reviews and gains alignment with functions affected by updated policies and procedures

REQUIREMENTS

Education Requirement(s):

  • B.A./B.S. in Life Sciences, Engineering, or similar discipline required
  • M.S. in Life Sciences/engineering/or similar discipline preferred
Skill & Competency

Requirements:
  • 2 - 6 years' experience in medical device industry

  • 1 - 3 years of directly related quality or regulatory experience

  • Working knowledge of Quality System Regulations and US, Canada, and EU medical device requirements

  • Demonstrated high performance orientation, detail orientation, organization skills

  • Excellent written, listening, and verbal communication skills;

  • Business Computer Skills and Business Applications

If interested, apply below or send your resume to Gary McAfee at gary.mcafee@ctg.com. Please reference job #19202964 in the subject line.

CTG's Benefits Plan allows you to select insurance coverage that best suits your lifestyle, and take part in our savings programs and educational plans. We offer Flexible Spending Accounts, a 401(k) Retirement Plan, and an Employee Stock Purchase plan. Our educational plan comprises access to more than 2,000 web-based technical, professional and business development courses.

CTG (NASDAQ: CTG) provides industry-specific IT services and solutions that address the business needs and challenges of clients in high-growth industries in North America and Western Europe. CTG also provides strategic staffing services for major technology companies and large corporations. Backed by more than 50 years of experience and proprietary methodologies, CTG has a proven track record of reliably delivering high-value, industry-specific staffing services and solutions to its clients. CTG has operations in North America, Western Europe, and India.

CTG's greatest asset is its people, and as such, we are committed to providing employees programs and processes to support their performance, hone their skills, and advance in their careers. This commitment is reflected by CTG being named a Best Places to Work in Healthcare company by Modern Healthcare (2013-2016) in North America, and a Best Workplace in the United Kingdom (2013), Belgium (since 2007), and Luxembourg (since 2011).

CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.

CTG is an Equal Opportunity/Affirmative Action Employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.


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Regulatory Affairs Specialist

CTG