Regulatory Affairs Specialist Job at EPM Scientific, Philadelphia, PA

bERtYXhSSytWczBaSkpHck91dHdON3duSEE9PQ==
  • 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

SPECTRAFORCE

Investment Compliance Specialist Job at SPECTRAFORCE

Job Description Title: Compliance Analyst Duration: Full-Time/Permanent Location: Alpharetta, GA- Onsite We are seeking a highly motivated Compliance Analyst to join our firm in Alpharetta, Georgia. This role is key to ensuring trading activities comply with...

Ultimate Staffing

Regulatory Affairs Specialist Job at Ultimate Staffing

 ...Ultimate Staffing Services is actively seeking a dedicated Regulatory Affairs Specialist to join their client's team in Union, California....  ...background in regulatory submissions and experience in the medical device industry. Responsibilities Manage and support... 

ADVANCED OXYGEN THERAPY INC.

Medical Sales Representative - Queens, NY (Uncapped Commission) Job at ADVANCED OXYGEN THERAPY INC.

 ...must reside within or near the assigned territory. Compensation ~ Base Salary Range: $70,000 $90,000 ~ Uncapped Commission:Earn up to $300,000 annually Benefits In addition to competitive pay, we offer a comprehensive benefits package that... 

Black Diamond Distribution LLC

Low Voltage Technician Job at Black Diamond Distribution LLC

Job Summary We are seeking a skilled and motivated Low Voltage Technician to join our team. The ideal candidate will have experience in installing, maintaining, and troubleshooting low voltage systems, including security systems, alarm systems, and computer networking... 

Atlas Professionals

Project Manager - Offshore Renewables Job at Atlas Professionals

 ...Our global subcontracting client is seeking a Project Manager to support their efforts on a major submarine cable installation project...  ...distance of Cranford, NJ as this position is onsite. This is a contract position set to last through the end of October. Prior experience...