Senior Regulatory Affairs Specialist - MedTech Surgery at Johnson & Johnson

Cincinnati, Ohio, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

MedTech, Surgery, HealthcareIndustries

Requirements

Regulatory Affairs experience in the medical device industry with a track record of successful US and OUS submissions supporting commercial medical devices
Passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art Class II and Class III medical devices
Energized by joining a world-class company and regulatory team
Enjoy teamwork and thrive as a member of dynamic cross-functional teams
Build and maintain strong interpersonal relationships within and outside of the company
Exhibit leadership traits - positive, forward looking, accountable, action-oriented, delivering results
Be adaptable and thrive in a dynamic work environment where variety is the routine
Embrace change, continuous learning, and work skills improvement
Able to manage (inferred from truncated "Able to mana")

Responsibilities

Prepare and submit regulatory documents, including applications for product registrations, amendments, annual renewals to respective health authorities and Notified Bodies (e.g. US FDA, TUV)
Collaborate with regional regulatory partners as needed in preparing submissions for global expansion
Evaluate proposed changes for regulatory impact and perform any required regulatory submissions/amendments
Maintenance of licenses throughout product lifecycle
Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes in responsible jurisdictions
Provide regulatory support for internal and external audits (e.g. MDSAP)
Monitor and anticipate changes in regulations in responsible jurisdictions
Prepare regulatory documents (e.g. CFG) to support global expansions or tenders

Skills

Key technologies and capabilities for this role

Regulatory AffairsMedTech RegulationsFDA ComplianceMedical Device RegulationsRegulatory Submissions

Questions & Answers

Common questions about this position

Is this role remote or hybrid, and where is it located?

This role works a Flex/Hybrid schedule and is based in the Cincinnati, OH office. There is NO remote option and relocation assistance is not provided.

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

Responsibilities include preparing and submitting regulatory documents to health authorities like US FDA and TUV, collaborating with regional partners for global submissions, evaluating changes for regulatory impact, maintaining licenses, developing multi-country strategies, and providing audit support.

What is the salary or compensation for this position?

This information is not specified in the job description.

What kind of team and work environment can I expect?

You'll join the Surgery team at Johnson & Johnson MedTech, working closely and partnering with internal departments as an individual contributor to support the Torax Medical business in heart recovery innovations.

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

A strong candidate combines knowledge of scientific, regulatory, and business issues, with experience preparing submissions to US FDA and Notified Bodies, evaluating regulatory impacts, maintaining licenses, and developing global 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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