Sr Regualtory Affairs Specialist
at HumCap Recruiting

Date Posted: 5/4/2017

Job Description

Description: Job
Summary

This
position supports domestic and international regulatory compliance for products
produced and/or distributed.

Duties
And Essential Job Functions

Support
New Product Development (NPD) and design change projects by participating
in FMEA activity, ECN, Labeling, Advertising and Promotional material and
Design Reviews.
Provide
regulatory strategic planning and support for new 510K products and
indications through design control to submission.
Perform
regulatory review of Marketing and Engineering materials for New Product
and Line Extension launches.
Participate
on project teams to determine, communicate and maintain global regulatory
strategies.
Prepare
and create domestic and international regulatory submissions as well as
supports the maintenance of technical files.
Support
audits (TUV, FDA and Others) as required.
Provide
work direction/guidance as needed to other specialists or associates.
Lead
and support Regulatory Department Process Improvement Initiatives.

Experience/Skills
Required

Five
to seven years work experience in FDA-regulated industry.
Working
knowledge of domestic and international Medical Device Regulations.
Experience
in Orthopedics industry is preferred.
510(k)
and global submission and experience required.
Microsoft
skills (Excel, Word, Access)
Project
management and process improvement experience.

Required
Education

B.
S. or B. A. degree in scientific or technical discipline.
RAC
preferred
CQA,
or RAB certification a plus

Additional
Information

All
qualified applicants will receive consideration for employment without regard
to race, color, religion, sex, sexual orientation, gender identity, religion,
national origin, disability, veteran status, or other legally protected status.

For
more than two decades, this company has remained sharply focused on meeting the
needs of surgeons and their patients by rethinking clinical possibilities with
a focus on procedural efficiency, efficacy and uncompromised quality.

A
highly nimble and responsive company, they are a leading global innovator,
developer, manufacturer and marketer of specialty medical devices, surgical
implants and powered surgical instruments.

The
company’s success is driven by the ability to quickly develop and deliver
innovative, quality products focused on improving patient outcomes and offer
technically advanced, simple and cost-effective solutions for surgeons,
hospitals and patients. They have a state-of-the-art manufacturing facility and
world headquarters is located in Dallas, Texas; this allows them to offer
remarkable responsiveness to those who count on our products.

 

Job Snapshot

  • Employee Type: Full-Time
  • Location: Addison
  • Job Type: Other
  • Experience: Not Specified
  • Date Posted: 5/4/2017

About Us

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~Anonymous

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The interaction continues along the process as HumCap finds potential job matches from client companies. Applicants who closely match a client’s job description are informed about the opening and briefed on the requirements. With their approval, we can begin marketing their achievements and skills to the client business and support the applicant throughout the interview and hiring process.

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