Sr Regulatory Affairs Specialist
at HumCap Recruiting

Date Posted: 8/5/2017

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

About Us

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HumCap is committed to helping applicants find relevant and fulfilling jobs. As a recruiting company, we perform search services for local and national businesses and match professionals to the areas of expertise requested by our clients. The vast network of employers we work with provides HumCap with special access to positions that won’t be listed anywhere else. These special job postings increase a candidate’s chances of not only being hired but also of finding a job that best fits their skills and objectives.

Our access to employment opportunities spans a variety of industries, including software, high tech, financial services, and healthcare. If an applicant wants to utilize our services, we begin the process with an in-person interview between a recruiter and the applicant where we discuss their goals and employment history. After developing a complete understanding of each candidate’s current situation in regards to talents and career goals, HumCap can then seek out the best employment opportunities that match each applicant’s needs. We see each applicant as a unique entity – not another faceless number.

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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