Associate Director, Global Regulatory Affairs Diagnostics at Johnson & Johnson

Raritan, New Jersey, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, MedTech, BiotechnologyIndustries

Requirements

Expertise in regulatory affairs for in vitro diagnostics (IVD) and medical devices (MD), including companion diagnostics
Ability to prepare, review, and implement regulatory strategies for diagnostic products supporting therapeutic development
Experience coordinating and compiling global regulatory submissions to Health Authorities (HAs) such as U.S. FDA (CDRH), EU, PMDA
Skills in maintaining external contacts and negotiating with HAs for timely product registrations
Capability to provide guidance, support, and training to pharmaceutical project teams on IVD regulations and strategies
Proficiency in drafting/reviewing U.S. and EU Study Risk Determinations for investigational diagnostics
Experience partnering with diagnostic providers for submission of investigational and marketing applications (e.g., Q-submissions, IDEs, IVDR Performance Studies)
Ability to track and manage Requests for Information (RFI) from authorities and coordinate cross-functional responses
Strong communication skills for expediting approvals with HAs and notified bodies
Willingness to participate in Global Regulatory Team (GRT) meetings and provide updates

Responsibilities

Contribute to business objectives by preparing, reviewing, and implementing regulatory strategies for diagnostic products related to therapeutic development
Oversee coordination and compilation of global submissions for new IVD and MD to Health Authorities
Maintain external contacts and negotiate with HAs (U.S., EU, PMDA, others) for timely registration of diagnostic products
Provide guidance, support, and educational training to pharmaceutical project teams on IVD regulations and strategy
Draft and/or review U.S. and EU Study Risk Determinations for investigational diagnostic products in therapeutic clinical studies
Partner with diagnostic test providers to coordinate, compile, and submit investigational and new IVD applications (e.g., CDRH Q-submissions, IDEs, EU IVDR Performance Studies, marketing authorizations)
Track RFIs from regulatory authorities on diagnostic submissions and manage cross-functional responses
Communicate with HAs and notified bodies to expedite approval of diagnostic submissions
Participate in therapeutic product Global Regulatory Team (GRT) meetings and provide updates on diagnostics

Skills

Key technologies and capabilities for this role

Regulatory AffairsDiagnosticsPrecision MedicineRegulatory ScienceGlobal Regulatory StrategyFDA RegulationsClinical DevelopmentMedTech

Questions & Answers

Common questions about this position

Is this a remote position or does it require office work?

This is a hybrid role based in Raritan, NJ or Spring House, PA, with remote work options considered on a case-by-case basis if approved by the company.

What are the main responsibilities of this role?

The role involves developing regulatory strategies for diagnostic products, overseeing global submissions for IVDs and MDs, negotiating with health authorities, and providing guidance on in vitro diagnostic regulations to project teams.

What is the salary range for this position?

This information is not specified in the job description.

What is the work environment like at Johnson & Johnson Innovative Medicine?

The role offers an opportunity to work in a highly innovative and growing precision medicine business, collaborating with teams that develop treatments, find cures, and champion patients while pioneering from lab to life.

What locations can I apply from for this role?

The position is based in Raritan, NJ or Spring House, PA, but candidates from any location are invited to apply, with listed cities as examples only.

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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