Careers

Search Jobs Connect With Us

Regulatory Affairs Specialist

Job Attributes

Job Id:

17514

Job Category:

Clinical & Life Sciences

Job Location:

West Chester, PA  19380

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

 

Piper Companies is currently looking for a Regulatory Affairs Specialist in Exton, PA to work for a medical device company globally focused on orthopaedic and neuro products and services, to assist in providing regulatory expertise to new product development.

Responsibilities for the Regulatory Affairs Specialist Include:

  • Collaborate with New Product Development and provide regulatory expertise 
  • Engage with cross-functional teams to obtain relevant information and review of submission content
  • Hand on 510K involvement & presubmissions
  • Assist in preparation of global registration dossiers
  • Support compliance activities related to global regulations and international standard

Qualifications for the Regulatory Affairs Specialist Include:

  • 4-6 years of regulatory affairs or related/equivalent experience
  • RAC credential is a huge plus
  • Proven work experience with writing and authoring 510K
  • Knowledge of US regulatory and CE mark pertaining to Technical Files and Design Dossiers, ISO 13485, ISO 9001, MDR, MEDDEV, QSR,
  • Domestic and OUS regulatory experience
  • Bachelors Degree in Life Sciences or related degree

Compensation for the Regulatory Affairs Specialist Includes:

  • Salary Range commensurate to experience
  • Full Benefits: Cigna Healthcare, MetLife Dental, VSP Vision, 401(k) with Voya, and Paid Time Off

Please send all qualified resumes to Karen Pallone at kkpallone@pipercompanies.com 

Apply Now

CONTACT INFORMATION (Required)
RESUME (Required)
No file selected
x
Formats accepted: .doc / .docx / .pdf / .txt
Don't have a resume? Click here to fill out a short form.

Copy/paste your resume inside the text editor below:

ADDITIONAL INFORMATION (Required)
WORK HISTORY (Required)
Add another experience (optional)
EDUCATION (Required)
Add another degree (optional)
SKILLS (Required)
Add another skill (optional)

The following error(s) occurred:

Please wait while your job application is being processed. This may take a few moments.
New Search

Job Id:

17514

Job Category:

Clinical & Life Sciences

Job Location:

West Chester, PA  19380

Security Clearance:

No Clearance

Business Unit:

Piper Companies