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Regulatory Affairs Specialist (Medical Devices)

Job Attributes

Job Id:

20316

Job Category:

Clinical

Job Location:

Philadelphia, PA  19380

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

Piper Clinical Solutions is currently seeking a Regulatory Affairs Specialist based out Pennsylvania in a global biotechnology company. The Regulatory Affairs Specialist will be a part of an innovative and driven company working to better the health and lives of people through medical technologies.

**This is a long-term consulting opportunity**

Responsibilities for the Regulatory Affairs Specialist include:

  • Identification of potential international markets; monitoring needs of the market and changes in the regulatory environment
  • Working with the domestic regulatory affairs team to conduct research and provide recommendations on regulatory strategies
  • Ensure regulatory compliance for new and existing products
  • Submission of international regulatory documents to agencies around the world

Qualifications for the Regulatory Affairs Specialist include:

  • Experience with 510(k) submissions and a medical device background (MDR, ISO 13485, ISO 9001, etc.)
  • Familiarity with international regulatory affairs agencies and experience working with them
  • Must have a technical engineer background
  • Bachelor's Degree or higher

Compensation for the Regulatory Affairs Specialist includes:

  • Salary Range: Based on market rate and years of relevant medical device experience
  • Benefits: Healthcare, Dental, Vision, 401k

Please send resumes to achu@pipercompanies.com

 

Keywords:

Medical, medical technologies, technologies, health, quality, global, provider, global provider, regulatory affairs, innovation, clinical, clinical needs, patients, healthcare, healthcare providers, providers, vascular, interventional, vascular access, interventional access, surgical, cardiac care, urology, anesthesia, respiratory care, emergency medicine, 510(k), medical device, international, international regulatory affairs, regulatory affairs agency, manufacturer, medical device manufacturer, regulatory filings, international regulatory filings, ISO 13485

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Job Id:

20316

Job Category:

Clinical

Job Location:

Philadelphia, PA  19380

Security Clearance:

No Clearance

Business Unit:

Piper Companies