Regulatory Affairs Specialist Job at EPM Scientific, Philadelphia, PA

U25nSURPVmZzVE5UMjdTWjI3Unl4MlVnRlE9PQ==
  • EPM Scientific
  • Philadelphia, PA

Job Description

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

High Hotels Ltd.

Dual Hotel Housekeeping Manager Job at High Hotels Ltd.

 ...At High Hotels, hospitality isnt just what we do, its who we are. For over 35 years, High Hotels has been raising the bar in hospitality...  ...Suites in Ewing, NJ is looking for a Dual Housekeeping Manager. Dual Housekeeping Managers for High Hotels, LLC are responsible... 

Arrowhead Winch

Manufacturing Engineer Project Manager Job at Arrowhead Winch

Arrowhead Winch engineers and manufactures industrial winch, hoist and drive systems under the BRADEN, CARCO and Gearmatic brand names in Broken Arrow and Okmulgee, Oklahoma. We are seeking a talented Manufacturing Engineer Project Manager to join our team. This position...

JMJ Phillip Group

Wastewater Engineer Job at JMJ Phillip Group

A prominent manufacturer is seeking a Wastewater Engineer in the Cherokee County, South Carolina area. Candidates Must Have: ~3+ years of experience driving chemical process improvements ~ Bachelor's degree in engineering ~ Experience with preventive maintenance...

Will County Executive Office

Recycling Program Specialist Job at Will County Executive Office

 ...JOB VACANCY NOTICE DATE: January 8, 2026 JOB TITLE: Recycling Program Specialist DUTIES AND REQUIREMENTS: Develop, implement and assist in the scheduling and organizing of solid waste/environmental educational presentations to Will County businesses, residential... 

Harper Associates

Executive Personal Assistant Job at Harper Associates

 ...Executive/Personal Assistant: Rochester, MI Compensation: $80,000-$90,000 Search by Harper Associates Monday to Friday, 8:30 to 4:30pm (on-site) Are you a polished, professional Executive/Personal Assistant who has managed personal/household matters for their...