Sr Regulatory Affairs Specialist
at HumCap Recruiting

Date Posted: 8/5/2017

Job Description




position supports domestic and international regulatory compliance for products

produced and/or distributed.


And Essential Job Functions


New Product Development (NPD) and design change projects by participating

in FMEA activity, ECN, Labeling, Advertising and Promotional material and

Design Reviews.


regulatory strategic planning and support for new 510K products and

indications through design control to submission.


regulatory review of Marketing and Engineering materials for New Product

and Line Extension launches.


on project teams to determine, communicate and maintain global regulatory



and create domestic and international regulatory submissions as well as

supports the maintenance of technical files.


audits (TUV, FDA and Others) as required.


work direction/guidance as needed to other specialists or associates.


and support Regulatory Department Process Improvement Initiatives.




to seven years work experience in FDA-regulated industry.


knowledge of domestic and international Medical Device Regulations.


in Orthopedics industry is preferred.


and global submission and experience required.


skills (Excel, Word, Access)


management and process improvement experience.




S. or B. A. degree in scientific or technical discipline.




or RAB certification a plus




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.


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.


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.


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

“It’s not what you know but who you know that makes a difference”.


Looking for a job or thinking about a career change?

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.

Join the HumCap Recruiting Talent Network today and stay up-to-date on our openings as they continue to become available!

What is a Talent Network?

Talent Networks enhance your job search and application process. Whether you choose to apply or just leave your information, we look forward to staying connected with you.

Why Join?

  • Receive alerts with new job opportunities that match your interests
  • Share job opportunities through Social Media or email

Are you looking for a new job? Check out these current opportunities: IT Jobs and Sales Jobs