Regulatory Affairs Specialist Job at EPM Scientific, Philadelphia, PA

aGlzUVNWQkpvbjR6cG9oRCtXL2RHNDRGWHc9PQ==
  • 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

Host Healthcare

Local Contract Cath Lab Technician - $61-65 per hour Job at Host Healthcare

 ...Host Healthcare is seeking a local contract Cath Lab Technologist for a local contract job in Victorville, California. Job Description & Requirements ~ Specialty: Cath Lab Technologist ~ Discipline: Allied Health Professional ~ Start Date: 04/29/2025~ Duration... 

Domino's

Delivery Driver (01079) - *Must Have Your Own Vehicle* - 2795 University Dr Job at Domino's

 ...and a positive attitude . What were looking for in our Delivery Drivers: Ability to maintain food and team member safety Excellent...  ...record meeting company standards Access to an insured vehicle that can be used for deliveries Must be at least 18 years... 

Big Concerts

Concert Promoter Job at Big Concerts

 ...Big Concerts is seeking a concert promoter for national shows. The concert promoter /talent buyer would be responsible for acquiring talent and booking venues for live events nationally. This position requires travel. Duties are included but not limited to: Talent buying... 

IKEA

Retail Sales Associate - Self Serve Job at IKEA

 ...IKEA - JobID: 288074 [Sales Associate / Team Member] As a Retail Sales Associate at IKEA, you'll: Proactively engage the customer in various departments in order to provide in depth product knowledge; Refer customers to the specialized selling teams; Offer IKEA Family... 

Vinsys Information Technology Inc

Quality Engineer | SDET | Job at Vinsys Information Technology Inc

 ...potentially sit at other hubs if necessary)Interview Process: BERY Technical & 2 rounds (1 hour long each) via zoomWalmart team: International ecommerce team focused on WCP foundational platform.Responsibilities: Contribute to and drive the end-to-end testing...