Regulatory Affairs Specialist Job at EPM Scientific, Philadelphia, PA

WWIvd2xtYXc0QmVnaFU5NFkvR1FrdHhYaXc9PQ==
  • 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

Northrop Grumman Corporation

Sr. Principal Electronics Engineer - Supplier Management Team (SMT) Lead (San Diego) Job at Northrop Grumman Corporation

 ...RELOCATION ASSISTANCE: Relocation assistance may be availableCLEARANCE TYPE: Secret TRAVEL: Yes, 25% of the Time Description At Northrop Grumman, our employees have incredible opportunities to work on revolutionary systems that impact people's lives around the world... 

Integrated Resources, Inc ( IRI )

Clinical Manufacturing Associate Job at Integrated Resources, Inc ( IRI )

 ...Manufacturing Associate This role is Onsite in Warren Responsibilities: Production of blood component lots through cell culture, harvest, and cryopreservation. Aseptic technique Become fully trained and qualified in all aspects of assigned processes Develop a... 

Horizon Air

Horizon Air - Flight Attendant Job at Horizon Air

**Company** Horizon Air**The Team**As a Horizon Air flight attendant, you'll fly regionally throughout the West, creating signature...  ...audio assessment which will take approx 40 minutes to complete.Training Requirement: training will be held in Portland, OR and... 

Klendworth Project Company, LLC

Farm Equipment Operator Job at Klendworth Project Company, LLC

Position: Farm Equipment Operator Pay: $50,000/ year + bonuses Key Responsibilities: Operate advanced farm equipment, including tractors, planters, sprayers, and harvesters, to carry out field operations such as planting, fertilizing, spraying, and harvesting... 

Insteel Industries

Industrial Engineer I Job at Insteel Industries

 ...Job Description Job Description Industrial Engineer I Position Snapshot Identifies, develops, justifies, implements, and follows...  ...engineering. Entry level to three years work-related experience. Internship experience strongly preferred. Physical Demands The...