Paid Regulatory Affairs Intern — NGS & Global Submissions

PGD Personal Genome Diagnostics Inc.; Baltimore (MD); On-site; USD 25,000 - 36,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life Insurance

STD/LTD

401(k)

PTO / Flexible Time Off

Tuition Reimbursement

Employee Stock Purchase Plan

Job summary

Labcorp is seeking a Regulatory Affairs Intern to join the Regulatory Team in Baltimore, MD. The 11-week paid internship offers hands-on work supporting regulatory submissions, literature reviews, and understanding US and EU medical device requirements, with relocation assistance for qualified candidates.

You'll gain exposure to PGDx products and NGS technology while collaborating with cross-functional stakeholders and senior leaders in a global healthcare environment.

Qualifications

• Current enrollment in a Bachelor’s degree program in Biology, Biomedical Engineering, Public Health, Genetics or Regulatory.
• Demonstrate strong attention to detail
• Eagerness to learn new skills and scientific concepts
• Show initiative and the ability to work independently under general supervision
• Maintains professionalism, including punctuality and appropriate conduct
• Strong communication skills; both written and verbal
• Actively participates in training sessions and applies newly learned skills accordingly
• Looking for practical experience with US and global medical device quality and regulatory requirements
• Can deliver results in an academic or professional setting.
• Ability to collaborate with various stakeholders and internal/external colleagues.

Responsibilities

• Review literature protocols and data sources.
• Execute literature reviews using scientific databases on NGS market, devices and competitors.
• Research genetic variants with potential clinical significance for PGDx therapies.
• Investigate requirements to submit information to ethical committees and competent authorities for EU trials.
• Learn NGS technology and US/global medical device requirements.
• Participate in regulatory body submissions and post-market surveillance data reporting.
• Perform related duties as assigned by supervisor.
• Maintain compliance with all company policies and procedures.

Skills

Attention to detail

Regulatory interest

Education

Bachelor’s degree in Biology/Biomedical Engineering/Public Health/Genetics/Regulatory

Job description

Labcorp is seeking a Regulatory Affairs Intern to join the Regulatory Team in Baltimore, MD. The 11-week paid internship offers hands-on work supporting regulatory submissions, literature reviews, and understanding US and EU medical device requirements, with relocation assistance for qualified candidates.

You'll gain exposure to PGDx products and NGS technology while collaborating with cross-functional stakeholders and senior leaders in a global healthcare environment.