Top 221 Affairs manager Jobs in Princeton, Nj

Regulatory and Clinical Affairs Specialist
EDDA TECHNOLOGY, INC. —Princeton, NJ
- $140,000 - $190,000 a year
- Full-time
- 5 years
- Engineering
- Office
- Health insurance
- Dental insurance
Quick Apply
Director, Internal & Employee Communications
Rocket Pharmaceuticals —Cranbury, NJ
- $188,000 - $250,000 a year
- Full-time
- SharePoint
- Senior level
- Business
- Paid holidays
- Health insurance
Associate Director, Business Insights and Analytics
Genmab —Princeton, NJ
- $163,920 - $245,880 a year
- Online Application
- 7 years
- Management
- Office
- Commuter assistance
- Paid parental leave
8d
Associate Director, Training
Genmab —Princeton, NJ
- $175,520 - $263,280 a year
- Online Application
- HIPAA
- Office
- Bachelor's degree
- Commuter assistance
- Paid parental leave
Manager, REMS Center of Excellence (Remote)
Sandoz —Princeton, NJ
- $91,400 - $169,700 a year
- Full-time
- Hybrid work
- Bachelor of Science
- Bachelor's degree
- Travel
- Health insurance
- Dental insurance
Manager, Corporate Meetings, Princeton, NJ - Hybrid
Sun Pharmaceutical Industries, Inc (USA) —Princeton, NJ
- $110,500 - $135,000 a year
- Hybrid work
- 6 years
- Marketing
- Bachelor's degree
- Disability insurance
- Health insurance
7d
Senior Administrative Assistant, US Medical Affairs
Genmab —Princeton, NJ
- $72,240 - $108,360 a year
- Online Application
- Research
- Office
- Microsoft Office
- Commuter assistance
- Paid parental leave
Clinical Data Management Manager
Integra LifeSciences —Princeton, NJ
- $109,250 - $149,500 a year
- Email
- Hybrid work
- Data analysis skills
- Office
- Analysis skills
- Disability insurance
- Health insurance
12d
Manager - Semiconductor Operations
Deloitte —Princeton, NJ
- $159,100 - $265,100 a year
- Full-time
- 6 years
- Up to 50% travel
- Engineering
5d
Sr. Manager, Medical Affairs Operations
Taiho Oncology, Inc. —Princeton, NJ
- $186,150 - $219,000 a year
- Full-time
- Hybrid work
- 5 years
- Finance
- Master's degree
- Paid time off
- Parental leave
Quick Apply
Manager, Regulatory Affairs - Cosmetics (Global)
Church & Dwight —Princeton, NJ
- $110,900 - $157,900 a year
- Full-time
- 8 years
- Senior level
- Leadership
- Profit sharing
- Paid parental leave
Regulatory Operations Senior Manager
Navitas Life Sciences —Princeton, NJ
- Full-time
- Bachelor's degree
- Senior level
- 10 years
Manager, MeRL Review
Genmab —Princeton, NJ
- $113,680 - $170,520 a year
- Online Application
- Bachelor's degree
- Organizational skills
- Training & development
- Commuter assistance
- Paid parental leave
Product Support Manager (Remote)
Lingraphica —Princeton, NJ
- $64,000 - $73,200 a year
- Full-time
- Remote
- Spanish
- Google Workspace
- 5 years
Quick Apply
8d
RA Manager
Sandoz —Princeton, NJ
- $114,100 - $211,900 a year
- Full-time
- Hybrid work
- Writing skills
- English
- Office
- Health insurance
- Dental insurance
Manager, Global Scientific Affairs
Abbott Laboratories —Princeton, NJ
- $113,300 - $226,700 a year
- Full-time
- Bachelor's degree
- Continuous improvement
- Doctor of Philosophy
- Health insurance
- Tuition reimbursement
13d
Speech Pathologist IP Diem Hopewell
Capital Health —Pennington, NJ
- $56.65 an hour
- 8 hour shift
- Remote
- Acute care
- Hospital
- BLS Certification
- Disability insurance
- Health insurance
Speech Pathologist IP Diem - Speech Inpatient - Varied Shifts - Trenton (RMC)
Capital Health —Trenton, NJ
- $56.65 an hour
- 8 hour shift
- Hospital
- BLS Certification
- Inpatient
- Disability insurance
- Health insurance
Director, Strategic Clinical Vendor Oversight and Relationship Lead (CRO)
Genmab —Princeton, NJ
- $193,280 - $289,920 a year
- Online Application
- 8 years
- Bachelor's degree
- Training & development
- Commuter assistance
- Paid parental leave
Associate Director, Marketing, Professional Promotion, Field Activation, (Head & Neck Oncology)
Genmab —Princeton, NJ
- $176,400 - $264,600 a year
- Online Application
- Salesforce
- Office
- 8 years
- Commuter assistance
- Paid parental leave

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affairs manager jobs near princeton, nj

Regulatory and Clinical Affairs Specialist

EDDA TECHNOLOGY, INC.
Princeton, NJ

Quick Apply

Job Details

Full-time
$140,000 - $190,000 a year

Benefits

Stock options
Health insurance
Dental insurance
401(k)
Flexible spending account
Paid time off
Parental leave
Vision insurance
Referral program

Qualifications

FDA submissions
Content creation for technical audiences
Technical documentation
ISO standards
510(k) submissions
Bachelor's degree
Regulatory affairs
Biomedical regulatory compliance
Regulatory submissions
Quality systems
Technical writing experience within technology
Robotics
ISO 13485

Full Job Description

Regulatory & Clinical Affairs Manager

Position Summary:

There is a Regulatory & Clinical Affairs Manager position available at EDDA Technology, Princeton, NJ.

The Regulatory & Clinical Affairs Manager will play a key role in supporting the Company’s regulatory and clinical initiatives across product development, regulatory submissions, and hospital collaborations.

This position is intended for a motivated professional seeking to grow into increasing levels of responsibility within a dynamic medical device environment. The successful candidate will be expected to independently manage assigned projects and develop well-reasoned regulatory recommendations, while working closely with cross-functional teams on overall regulatory and clinical strategy.

This role offers significant opportunities for professional growth, increased ownership, and direct exposure to executive-level strategic planning, regulatory agency interactions, and clinical partnerships.

The position combines regulatory affairs, clinical affairs, and hospital collaboration activities, supporting innovative AI-enabled medical imaging, surgical planning, surgical navigation, and digital health technologies.

Primary Responsibilities:

Regulatory Affairs

Preparation and execution of regulatory submissions, including FDA 510(k) submissions, software modifications, and international registrations as applicable.
Assess regulatory impact of software, AI/ML, cybersecurity, and product changes.
Develop regulatory strategies and recommendations for new products and software upgrades.
Support interactions with FDA, notified bodies, regulatory consultants, and international regulatory agencies.
Monitor evolving regulatory requirements and communicate potential impacts to the organization.
Support regulatory assessments related to design changes, risk management, verification, validation, and clinical evidence.

Clinical Affairs & Hospital Collaboration

Support preparation and submission of IRB applications, clinical study protocols, investigator documentation, study reports, and publications.
Coordinate collaborations with hospitals, physician investigators, and academic research partners, and assist in organizing collaboration activities.
Work closely with investigators and research coordinators to facilitate study execution, data collection, and project tracking.
Support development of clinical evidence for regulatory submissions, publications, and product validation.

Cross-Functional Collaboration

Partner closely with engineering teams to ensure regulatory requirements are incorporated throughout product development.
Collaborate with product management, marketing, clinical, and quality teams to support successful product commercialization.
Independently manage multiple regulatory and clinical projects while maintaining schedules and deliverables.

Qualifications:

5-10 years of experience in medical device regulatory affairs.
Experience preparing and/or leading FDA 510(k) submissions.
Experience with Software as a Medical Device (SaMD), AI/ML-enabled medical devices, medical imaging, surgical navigation, robotics, or digital health products.
Experience with EU MDR and Technical Documentation submissions.
Experience interacting with FDA, notified bodies, and clinical investigators.
Familiarity with medical device quality systems and standards, including ISO 13485, ISO 14971, and IEC 62304.
Experience supporting clinical studies, IRB submissions, or hospital-based research collaborations.
Strong technical writing, project management, and communication skills.
Experience working directly with engineering teams during product development.
Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, or related field.

Desired Characteristics:

Collaborative working style with the ability to build productive relationships across engineering, clinical, quality, and commercial teams.
Comfortable operating in a fast-paced, entrepreneurial medical device environment where responsibilities may evolve as the organization grows.
Strong learning agility and ability to quickly develop expertise in adjacent functional areas.
Comfortable taking ownership of new responsibilities beyond previous role boundaries.
Able to independently develop recommendations while seeking appropriate input from subject matter experts and leadership.

Company Introduction:

Excellent opportunity with a dynamic, growing medical technology solution company.

EDDA Technology is an innovative leader in the rapidly growing field of intelligent robotic solutions for precision surgery. Pioneering a “fully quantitative, interactive” approach to intelligent imaging analytics and robotic integration, the company has built a proprietary technology platform to facilitate pre-surgical planning and simulation, intra-operative navigation, post-operative evaluation. With its end-to-end enabling platform, EDDA’s goal is to form a comprehensive ecosystem of clinical practice, connection, and education to support physicians and patient management in all tiers of hospitals. IQQA® is a registered trademark of EDDA Technology. (www.eddatech.com)

Compensation/ Benefits

Salary Range: $140,000 - $190,000; compensation is based on experience, education, and relevant skills.

EDDA offers a competitive salary, performance-based incentive stock options, and excellent benefits including medical and dental insurance, vision care, 401k plan, section 125 health and dependent care (flexible spending) accounts, and paid vacations. The company sponsors the H1-B application.

Send applications to: [email protected]

Pay: $140,000.00 - $190,000.00 per year

Benefits:

401(k)
Dental insurance
Flexible spending account
Paid time off
Parental leave
Referral program
Vision insurance

Application Question(s):

How many years of work experience do you have with ISO 13485?
How many years of work experience do you have with ISO 14971?
How many years of work experience do you have with IEC 62304?
How many years of experience do you have in medical device regulatory affairs?
How many years of experience do you have in preparing and/or leading FDA 510(k) submissions?
How many years of experience do you have in supporting clinical studies, IRB submissions, or hospital-based research collaborations?
How many years of work experience do you have with AI/ML-enabled medical devices, medical imaging, surgical navigation, robotics, or digital health products?
How many years of work experience do you have with EU MDR and Technical Documentation submissions?
How many years of work experience do you have with FDA, notified bodies, and clinical investigators?
Will you now, or in the future, require sponsorship for employment visa status (e.g. H-1B visa status)?
Are you legally authorized to work in the United States?
How many years of work experience do you have with SaMD/SiMD submissions?

Ability to Commute:

Princeton, NJ 08540 (Required)

Work Location: In person

Quick Apply

Refine Your Search

affairs manager jobs in princeton, nj

Regulatory and Clinical Affairs Specialist

Director, Internal & Employee Communications

Associate Director, Business Insights and Analytics

Associate Director, Training

Manager, REMS Center of Excellence (Remote)

Manager, Corporate Meetings, Princeton, NJ - Hybrid

Senior Administrative Assistant, US Medical Affairs

Clinical Data Management Manager

Manager - Semiconductor Operations

Sr. Manager, Medical Affairs Operations

Manager, Regulatory Affairs - Cosmetics (Global)

Regulatory Operations Senior Manager

Manager, MeRL Review

Product Support Manager (Remote)

RA Manager

Manager, Global Scientific Affairs

Speech Pathologist IP Diem Hopewell

Speech Pathologist IP Diem - Speech Inpatient - Varied Shifts - Trenton (RMC)

Director, Strategic Clinical Vendor Oversight and Relationship Lead (CRO)

Associate Director, Marketing, Professional Promotion, Field Activation, (Head & Neck Oncology)

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