Principal Regulatory Affairs Specialist- Shockwave Medical at Johnson & Johnson

Santa Clara, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

MedTech, Healthcare, Medical DevicesIndustries

Requirements

Ability to serve as primary liaison between J&J Product Stewardship team and Shockwave stakeholders (R&D, Supply Chain, Quality, Regulatory Affairs, Finance, Packaging, Marketing, etc.)
Knowledge of global Product Stewardship activities, including Global REACH requirements, Global RoHS requirements, Global Battery Regulations, Global Packaging and Packaging Waste Regulations, and other environmental regulations
Capability to develop systems for intake, assessment, and tracking of worldwide environmental product and packaging compliance requirements
Experience liaising with new product development teams to integrate product stewardship and environmental sustainability requirements
Skills to work with internal and external stakeholders to meet worldwide reporting obligations for environmental and packaging requirements
Ability to create and/or update procedures to reflect changing environmental requirements and support data mining for compliance
Proficiency in advising management on trends in the global regulatory environment impacting current or future business
Competence in managing and providing updates on critical tasks for ongoing projects
Skill set for value-added individual contributions under moderate supervision
Ability to implement methods for planning, directing, coordinating, and controlling Product Stewardship regulatory affairs activities for new and modified products worldwide in compliance with corporate policies and strategies
Ability to interpret regulatory information

Responsibilities

Serve as the primary liaison between the J&J Product Stewardship team and Shockwave stakeholders to manage business risk and institutionalize product stewardship programs
Support global Product Stewardship activities associated with Global REACH, RoHS, Battery Regulations, Packaging and Packaging Waste Regulations, and other applicable environmental regulations
Develop systems for intake, assessment, and tracking of worldwide environmental product and packaging compliance requirements
Liaise with new product development teams to ensure product stewardship and environmental sustainability requirements are considered during new product design and launch
Work with internal and external stakeholders to ensure worldwide reporting obligations related to environmental and packaging requirements are met
Create and/or update procedures to reflect changing environmental requirements, ensuring processes support data mining for compliance demonstration
Advise management on trends in the global regulatory environment that may impact current or future Shockwave business
Manage and provide updates on critical tasks for ongoing projects
Develop skill set to enable value-added individual contributions working under moderate supervision
Implement methods for planning, directing, coordinating, and controlling Product Stewardship regulatory affairs activities related to new and modified products worldwide in compliance with corporate policies and strategies

Skills

Key technologies and capabilities for this role

Regulatory AffairsMedical DevicesMedTechIntravascular LithotripsyCardiovascular Devices

Questions & Answers

Common questions about this position

Is this position remote?

Yes, the position is fully remote and can be based anywhere in the US.

What is the salary range for this role?

This information is not specified in the job description.

What are the main responsibilities of this role?

The role serves as the primary liaison between the J&J Product Stewardship team and Shockwave stakeholders for product stewardship programs, supports global activities like REACH, RoHS, Battery Regulations, and Packaging Waste Regulations, and develops systems for tracking environmental compliance requirements.

What is the company culture like at Johnson & Johnson?

Johnson & Johnson emphasizes healthcare innovation to prevent, treat, and cure complex diseases with smarter, less invasive, and personalized solutions, fostering a pioneering team environment focused on developing Intravascular Lithotripsy (IVL) for cardiovascular disease.

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

Strong candidates will have expertise in global product stewardship, including REACH, RoHS, battery regulations, and packaging compliance, along with experience liaising across R&D, Supply Chain, Quality, Regulatory Affairs, and other functions to manage environmental compliance and business risk.

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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