Senior Regulatory Affairs Program Lead - Vision at Johnson & Johnson

Jacksonville, Florida, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, MedTech, Vision Care, PharmaceuticalsIndustries

Requirements

Minimum of a Bachelor's Degree required, Advanced Degree highly desired (desired areas of study include Science, Engineering, or related field)
Minimum of 6+ years of related Regulatory Affairs experience required (4+ years with Advanced Degree); Medical Device regulatory experience strongly preferred
Experience with Vision related medical device regulatory highly desired
Working knowledge of US FDA & EU MDR regulatory requirements & processes required
A demonstrated track record of developing and driving implementation of regulatory strategies
Working knowledge of how global regulations impact product registration
Good communication skills for effective collaboration with cross-functional partners
Corresponding and collaborating with J&J colleagues globally for strategic contribution and achievement of regulatory milestones
Evaluating new regulatory requirements
Must be based within a commutable distance of Jacksonville, FL, and work a Flex/Hybrid schedule with 3 days per week on-site

Responsibilities

Manages regulatory strategies for product development and lifecycle management
Provides independent regulatory guidance to product teams
Leads complex international and domestic submissions and approvals
Oversees conformance with regulations in claims, labeling, and promotion
Develops and approves regulatory documentation, including labeling and advertising
Coordinates and monitors regulatory project schedules and deliverables
Guides the development of regulatory policies and best practices
Supports regulatory audits, inspections, and compliance programs
Manages and influences relationships with health authorities
Oversees and mentors regulatory team members or vendors
Ensures alignment of regulatory activities with corporate strategic goals
Tracks global regulatory trends and implements proactive strategies
May provide supervision and direction to contract resources or employees

Skills

Key technologies and capabilities for this role

Regulatory AffairsRegulatory StrategySubmission ManagementComplianceProduct DevelopmentLifecycle ManagementRegulatory PlansMedTech RegulationsFDA Submissions

Questions & Answers

Common questions about this position

What is the work arrangement for this role?

This role follows a Flex/Hybrid schedule requiring 3 days per week on-site and candidates must be based within a commutable distance of Jacksonville, FL.

What are the main responsibilities of this position?

The role involves managing regulatory strategies for product development and lifecycle management, providing independent regulatory guidance, leading complex submissions, overseeing compliance, and mentoring team members.

Is there a salary range listed for this position?

This information is not specified in the job description.

What is the company culture like at Johnson & Johnson Vision?

The team is fueled by innovation at the intersection of biology and technology, focused on developing smarter, less invasive, personalized vision treatments, and solving tough health challenges through cutting-edge insights, science, and collaboration.

What makes a strong candidate for this Senior Regulatory Affairs Program Lead role?

Strong candidates should have strategic leadership experience in regulatory affairs, ability to manage complex international submissions, provide independent guidance to cross-functional teams, oversee compliance, and mentor resources.

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

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