Remote Senior Regulatory Affairs Leader, Lifecycle

Advita Ortho; United States; Remote; USD 150,000 - 190,000; Full time

Job summary

Advita Ortho is seeking a Sr Manager, Regulatory Affairs to lead the lifecycle regulatory activities for its postmarket products. You will manage a team, coordinate with regulatory bodies, and shape regulatory strategies across regions.

The role requires a strong background in medical device regulations, 10+ years of experience, and the ability to influence cross-functional partners. Remote work option in the US is available.

Qualifications

• Bachelor’s degree in physical or life sciences; Master’s degree preferred.
• Minimum 10 years in medical device regulatory affairs or related field.
• Experience with US/EU/international submissions/registrations.
• Regulatory leadership experience and ability to influence cross-functional teams.

Responsibilities

• Oversee lifecycle postmarket regulatory activities for Advita’s products.
• Lead regulatory strategy development and timelines for changes to products.
• Interface with Health Authorities and regulators on registrations and submissions.
• Ensure compliance with regulatory Conditions of Approval and post-launch A&P reviews.

Skills

Regulatory leadership

Stakeholder negotiation

MS Office

Education

Bachelor’s degree

Master’s degree preferred

Tools

Microsoft Office

Job description

Advita Ortho is seeking a Sr Manager, Regulatory Affairs to lead the lifecycle regulatory activities for its postmarket products. You will manage a team, coordinate with regulatory bodies, and shape regulatory strategies across regions.

The role requires a strong background in medical device regulations, 10+ years of experience, and the ability to influence cross-functional partners. Remote work option in the US is available.