Regulatory Affairs Specialist Job at EPM Scientific, Philadelphia, PA

Y1ZXT3VZZnM1THhzNTg3RG9UbVAyMkpndFE9PQ==
  • 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

Hobson Prior

Principal Investigator Job at Hobson Prior

 ...Hobson Prior is seeking a Principal Investigator to ensure the safety of participants in clinical trials and oversee the study process according to approved guidelines. You will play a crucial role in advancing medical research by ensuring studies are conducted safely... 

EVONA

Electrical Engineer - Power Electronics Job at EVONA

 ...Electrical Engineer Power Electronics San Francisco Bay Area My client are an exciting new Space company and they are looking for...  ..., and verifying power subsystem performance during spacecraft assembly, integration, and testing (AIT). Ideal Qualifications:... 

Eliassen Group

Agile Project Manager/ Scrum Master Job at Eliassen Group

**Agile Project Manager/ Scrum Master****Anywhere****Type:** Contract-to-Hire**Category:** Scrum Master**Industry:** Technology**Workplace Type:** Remote**Reference ID:** JN -042025-101455**Date Posted:** 03/31/2025**Shortcut:** + Description+ Recommended Jobs... 

Elsdon Group

Construction Project Manager Job at Elsdon Group

 ...this is a great opportunity for a Project Manager looking for long-term career growth with a firm that values integrity, teamwork, and...  ...met. Oversee subcontractor procurement, scope definition, contract negotiations, and change order management. Ensure all work is... 

Code Red Partners

Security Researcher Job at Code Red Partners

 ...Join an early-stage startup thats building at the frontier of AI and cybersecurity. Theyre on a mission to design autonomous security systems capable of detecting, triaging, and remediating software vulnerabilities, all without human intervention! This is a greenfield...