Senior Regulatory Affairs Specialist - Vision at Johnson & Johnson

Irvine, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

MedTech, Healthcare, Vision Care, Medical DevicesIndustries

Requirements

Minimum of a Bachelor’s Degree is required, Scientific Discipline strongly preferred
At least 4+ years of relevant related experience within a regulated environment or equivalent experience in another relevant function such as Quality, Medical, Clinical, R&D
Demonstrated experience with Regulatory LCM and 510k assessments highly desired
Prior experience with Class II or Class III Medical Devices strongly preferred
Experience interacting directly with US FDA required, EU MDR experience preferred
Ability to effectively manage multiple projects and priorities
Strong communication and regulatory writing skills
Strong problem solving skills, interpersonal skills and effective team member
Results oriented. Ability to drive to completion in adherence to aggressive project schedules
Must be based within a commutable distance of Irvine, CA or Milpitas, CA (Hybrid/Flex schedule with 3 days per week on-site)

Responsibilities

Provides strategic regulatory guidance throughout product lifecycle stages
Leads preparation and submission of licensing, registration, and approval dossiers
Coordinates complex regulatory activities, including post-market modifications
Ensures conformance of product labeling, claims, and promotional materials
Develops regulatory strategies and plans for new product development
Reviews and approves labeling, packaging, and promotional content
Supports audits and inspections to ensure compliance
Guides and trains junior team members on regulatory processes
Maintains and monitors regulatory compliance across markets
Liaises with health authorities during inspections and inquiries
Tracks regulatory developments and advises on impact
Participates in cross-functional project teams at a leadership level
May supervise work of contract resources or interns

Skills

Key technologies and capabilities for this role

Regulatory AffairsProduct Lifecycle ManagementRe-registrationLabeling ReviewFDA RegulationsMedical Device RegulationsVision Care Regulations

Questions & Answers

Common questions about this position

What is the work arrangement for this role?

This role works a Hybrid/Flex schedule with 3 days per week on-site and candidates must be based within a commutable distance of Irvine, CA or Milpitas, CA.

What are the main responsibilities of the Senior Regulatory Affairs Specialist?

Responsibilities include providing strategic regulatory guidance, leading preparation and submission of dossiers, coordinating regulatory activities, ensuring labeling compliance, developing strategies for new products, supporting audits, and guiding junior team members.

What salary or compensation is offered for this position?

This information is not specified in the job description.

What is the company culture like at Johnson & Johnson's Vision team?

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

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

Strong candidates should have expertise in providing regulatory support for product lifecycle activities with minimal supervision, experience leading complex regulatory submissions and strategies, and the ability to guide junior team members and participate in cross-functional leadership.

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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