Regulatory Affairs Specialist

EPM Scientific; Philadelphia (Philadelphia County); On-site; USD 65,000 - 111,000; Full time

Job summary

A global leader in ophthalmic medical devices is seeking a Regulatory Affairs Specialist to support innovative product development in Pennsylvania. Ideal candidates should possess a strong technical background, relevant experience in regulatory affairs, and excellent communication and problem-solving skills. This is a full-time, on-site position offering a competitive salary in an advancing field.

Qualifications

• 3+ years of regulatory affairs experience in medical device industry.
• Proven track record with successful 510(k) submissions.
• Willingness to work on-site at Pennsylvania location.

Responsibilities

• Provide regulatory support for medical device projects from development through post-market stages.
• Coordinate and prepare global regulatory submission documents with cross-functional input.
• Monitor changes in regulatory requirements and communicate potential impacts to internal stakeholders.

Skills

Strong communication

Problem-solving

Education

Bachelor's or master's degree in engineering or a technical field

Job description

Direct message the job poster from EPM Scientific

Regulatory Affairs - Recruitment Consultant

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

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

• Industries

  Medical Equipment Manufacturing

Referrals increase your chances of interviewing at EPM Scientific by 2x

Sign in to set job alerts for “Regulatory Affairs Specialist” roles.

Philadelphia, PA $65,200.00-$110,800.00 2 months ago

Greater Philadelphia $80,000.00-$90,000.00 1 week ago

Greater Philadelphia $110,000.00-$120,000.00 1 week ago

Compliance & Quality Assurance Specialist

Philadelphia, PA $45,000.00-$52,000.00 3 weeks ago

Sr Regulatory Affairs-Quality Specialist

Malvern, PA $80,000.00-$110,000.00 1 month ago

Administrative Coordinator, Safety Quality Regulatory - Pennsylvania Hospital

Quality Assurance Specialist I, Raw Material Release [Contract to Hire]-Wed to Saturday-7am-6pm

Lansdale, PA $85,600.00-$134,800.00 15 hours ago

Regulatory Correspondence Spec I (Onsite)

Clinical Research Regulatory Specialist B (Abramson Cancer Center)

Associate Director, Global Regulatory Affairs

Quality Reporting & Accreditation Specialist

Philadelphia, PA $60,000.00-$70,000.00 1 week ago

Senior Quality Assurance Specialist, Investigations

Lead Regulatory Scientist, Global Regulatory Affairs (Oncology)

Spring House, PA $105,000.00-$169,050.00 4 days ago

Quality Assurance Analyst (Regulatory) CVPF (Center for Cellular Immunotherapy)

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.