Senior Regulatory Affairs Program Lead - Electrophysiology at Johnson & Johnson

Irvine, California, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

MedTech, Healthcare, CardiovascularIndustries

Requirements

Expertise in interpreting global regulations and policies for project teams and management
Proficiency in regulatory requirements, including FDA interactions and rapport-building with reviewers
Experience developing IDE, 510K, PMA submissions, and EU Technical Documents for medical devices
Ability to represent regulatory function as a subject matter expert on project teams
Strong collaboration skills with cross-functional teams to resolve complex regulatory issues
Capability to coach project teams and junior colleagues on regulatory processes, labeling, claims, and materials
Knowledge of submission negotiations with regulatory authorities throughout product lifecycle
Team player mindset, cooperative with all functional groups

Responsibilities

Ensure compliance with global regulations and agencies
Instill and drive a regulatory culture; establish policies and standards for new products
Represent regulatory function on project teams, providing guidance and developing worldwide strategies
Coach teams on product labeling, claims support, promotional/scientific materials, and development compliance
Work collaboratively with cross-functional teams to resolve complex regulatory issues
Develop IDE, 510K, PMA submissions, and EU Technical Documents for US commercialization
Generate documentation for worldwide regulatory agency submissions to secure market approvals
Conduct submission negotiations with authorities for timely approvals of new products/modifications
Maintain proficiency on regulations and rapport with FDA reviewers/project members
Provide regulatory education and information to product development, marketing, and clinical groups
Perform Copy Review for internal/external documentation to ensure compliance
Provide support for internal/external regulatory agency audits
Coach junior colleagues in techniques, processes, and responsibilities

Skills

Regulatory Affairs

Regulatory Strategy

Global Commercialization

Regulatory Compliance

Electrophysiology

Cardiovascular

MedTech

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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