Regulatory Affairs Specialist Job at EPM Scientific, Philadelphia, PA

bFZrTTY1V3dQZXQyOW9BVGM5NE1aRXNTK1E9PQ==
  • EPM Scientific
  • Philadelphia, PA

Job Description

Title: Regulatory Affairs Specialist

Summary:
A global leader in the ophthalmic medical device industry, is seeking an experienced and driven Regulatory Affairs Specialist to join their team in Pennsylvania. This position is perfect for a candidate with strong communication and problem-solving skills who is passionate about advancing medical technology. This is a great opportunity to join a cutting-edge organization and play a key role in shaping regulatory strategy and supporting innovative product development.

The Regulatory Affairs Specialist should have the following qualifications:

  • Bachelor's or master's degree in engineering or a technical field
  • 3+ years of regulatory affairs experience in the medical device industry
  • Proven track record with successful 510(k) submissions
  • Willingness to work on-site at our Pennsylvania location
  • Ability to work effectively with cross-functional and risk management teams

Responsibilities of the Regulatory Affairs Specialist include:

  • Provide regulatory support for medical device projects from development through post-market stages
  • Coordinate and prepare global regulatory submission documents with cross-functional input
  • Develop and maintain procedures and work instructions to ensure ongoing regulatory compliance
  • Collaborate closely with product development teams to implement global regulatory strategies
  • Monitor changes in regulatory requirements and communicate potential impacts to internal stakeholders

Job Tags

Similar Jobs

Activ8 Recruitment & Solutions

Air & Ocean Import/Export Coordinator (#31906) Job at Activ8 Recruitment & Solutions

 ...A global logistics company near the DFW International Airport is seeking a motivated entry-level individual with a strong interest in international logistics coordination. This role involves air / ocean Import/ Export logistics operations , coordinating shipments... 

Aritzia

Stock Associate Job at Aritzia

THE TEAM The mission of the Inventory Management Department is to enable a curated merchandise assortment and seamless retail environment to create exceptional shopping experiences. THE OPPORTUNITY Aritzia is growing, and our Inventory Management team in Retail...

Softcom Systems Inc

Licensed Massage Therapist Job at Softcom Systems Inc

 ...skilled Massage Therapist to join our team. This position offers the unique opportunity to set your own schedule, with weekends (Saturday & Sunday) as a required commitment. Requirements Obtain current up to date Massage Therapy license in the state of... 

Continental Travel Group

Corporate & Leisure Travel Agent Job at Continental Travel Group

 ...The Continental Travel Group: Corporate Travel Consultant & Leisure Travel Consultants Includes Free Training Join our Thriving and Dynamic Team! (We are not a call center!) The Continental Travel Group is in search of a Corporate Travel Consultant to join our... 

NileVista, Inc.

Entry Level Marketing Job at NileVista, Inc.

 ...looking to hire immediately for this on-site role. Our company offers extensive paid training and career development opportunities. Entry Level Marketing Responsibilities: Effectively communicate with customers in a retail setting Present the customers with products...