Senior Regulatory Affairs Specialist (WCH & Biosurgery) - MedTech Surgery at Johnson & Johnson

Raritan, New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

MedTech, Healthcare, Surgery, Medical DevicesIndustries

Requirements

Passionate about improving and expanding the possibilities of surgery
Ability to work a Flex/Hybrid schedule based in the Raritan, N.J. office (NO remote option)
Expertise in regulatory affairs for medical devices, including European Notified Body, BSI, European MDR, and FDA submissions
Ability to provide regulatory guidance under minimal supervision
Knowledge of applicable regulations and guidelines for new, modified, and currently marketed medical devices
Experience working with cross-functional project teams
Capability to research, collect data, and prepare regulatory documentation

Responsibilities

Ensures compliance with regulatory agency regulations and interpretations
Prepares responses to regulatory agencies' questions and other correspondence
Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines
Provides solutions to a variety of problems of moderate scope and complexity
Researches and collects data; responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, and provides routine regulatory information to associates and affiliates
Advises on regulatory labeling requirements specifications for modified products, and reviews product labeling to ensure compliance
Provides regulatory guidance to project teams and responds to product information requests
Provides Regulatory Affairs support during internal and external audits and assists in leading the development of best practices for Regulatory Affairs
Represents Regulatory Affairs on cross-functional project teams
Communicates business related issues or opportunities to next management level
Follows all Company guidelines related to Health, Safety and Environmental practices
For those who supervise or manage a staff, ensures that subordinates follow applicable guidelines

Skills

Key technologies and capabilities for this role

Regulatory AffairsRegulatory SubmissionsStrategic PlanningMedTech RegulationsWound ClosureBiosurgeryProject Team Guidance

Questions & Answers

Common questions about this position

Is this role remote or hybrid?

This role works a Flex/Hybrid schedule and is based in the Raritan, N.J. office, with no remote option available.

What are the main responsibilities of this position?

The role involves providing regulatory guidance to project teams, developing and executing regulatory strategies for medical devices, preparing submissions to authorities like FDA and European Notified Bodies, ensuring compliance, and preparing responses to regulatory agencies.

What salary or compensation does this role offer?

This information is not specified in the job description.

What is the work environment like at Johnson & Johnson Surgery?

The Surgery team is fueled by innovation at the intersection of biology and technology, developing smarter, less invasive, more personalized treatments, and reimagining how we heal to treat conditions like obesity, cardiovascular disease, and cancer.

What experience makes a strong candidate for this role?

Strong candidates have expertise in regulatory affairs for medical devices, experience with submissions to FDA and European authorities like BSI and MDR, ability to work under minimal supervision, and skills in guiding cross-functional teams on compliance and strategies.

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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