Top 62 Affairs manager Jobs in New Haven, Ct

Manager of Regulatory Affairs & Customer Quality
Forum Contract Manufacturing —Watertown, CT
- $75,000 - $90,000 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Bachelor of Science
- Health insurance
- Dental insurance
Quick Apply
3d
Specialty Business Manager, Derm - Stamford, CT
Takeda Pharmaceutical —Connecticut
- $140,000 - $192,500 a year
- Full-time
- Remote
- Private practice
- Hospital
- Bachelor of Science
- Paid holidays
- Disability insurance
7d
Medical Coding and Billing Assistant 1
Yale University —New Haven, CT
- $31.83 an hour
- Full-time
- Remote
- Background check
- Anatomy knowledge
- Microsoft Outlook
Prin Regulatory Affairs Spec
Medtronic —North Haven, CT
- $120,000 - $180,000 a year
- Full-time
- 5 years
- Office
- Bachelor's degree
- Health savings account
- Employee stock purchase plan
Compliance Manager
Athletic Brewing Company LLC —Milford, CT
- $95,000 - $125,000 a year
- Full-time
- Hybrid work
- 5 years
- Office
- Bachelor's degree
- Paid parental leave
- Health insurance
Compliance Auditor
Yale University —New Haven, CT
- $68,000 - $120,500 a year
- Full-time
- Remote
- Microsoft Word
- Background check
- Nursing
Sr. Associate Director, Professionalism and Leadership
Yale University —New Haven, CT
- $105,000 - $174,000 a year
- Full-time
- Hybrid work
- Background check
- Writing skills
- 8 years
Account Assistant 4
Yale University —New Haven, CT
- $31.83 an hour
- Full-time
- Remote
- Background check
- Microsoft Excel
- High school
YM Compliance Educator
Yale University —New Haven, CT
- $82,000 - $131,500 a year
- Full-time
- Remote
- Microsoft Word
- Background check
- Nursing
Program Manager, YSM Faculty Affairs
Yale University —New Haven, CT
- $68,000 - $120,500 a year
- Full-time
- Hybrid work
- Background check
- School experience
- Mid-level
6d
Assistant Vice President
Yale University —New Haven, CT
- Full-time
- Hybrid work
- Background check
- Research
- 8 years
Director, McDougal Graduate Student Center and Student Life
Yale University —New Haven, CT
- $90,000 - $165,750 a year
- Full-time
- Hybrid work
- Background check
- 5 years
- Master's degree
Coding and Billing Analyst
Yale University —New Haven, CT
- $68,000 - $120,500 a year
- Full-time
- Remote
- Microsoft Word
- Background check
- Microsoft Outlook
YM New Provider Auditor and Educator
Yale University —New Haven, CT
- $82,000 - $131,500 a year
- Full-time
- Remote
- Microsoft Word
- Background check
- Anatomy knowledge
Assistant Controller
Yale University —New Haven, CT
- $120,000 - $225,000 a year
- Full-time
- Hybrid work
- Background check
- 7 years
- CPA
Senior Administrative Assistant, Presidential Senior Fellowship Program
Yale University —New Haven, CT
- $31.83 an hour
- Part-time
- Hybrid work
- Background check
- Microsoft Excel
- Microsoft Outlook
Program Manager, Research Affairs
Yale University —New Haven, CT
- $68,000 - $120,500 a year
- Full-time
- Hybrid work
- Background check
- Mid-level
- Master's degree
Enrollment Management Specialist
Connecticut State Community College —Waterbury, CT
- $56,881 a year
- Weekends as needed
- Background check
- Spanish
- Microsoft Excel
- Health insurance
- Tuition reimbursement
6d
Practical Nurse
US Veterans Health Administration —West Haven, CT
- $61,290 - $79,676 a year
- Online Application
- Background check
- Nursing
- Patient monitoring
- Paid parental leave
- Paid holidays
14d
Manager- Global CAPA System
CooperSurgical —Trumbull, CT
- $120,000 - $170,000 a year
- Full-time
- Engineering
- Office
- Master's degree
- Health insurance
- Paid time off

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Manager of Regulatory Affairs & Customer Quality

Forum Contract Manufacturing
Watertown, CT

Quick Apply

Job Details

Full-time
$75,000 - $90,000 a year
3 days ago

Benefits

Health insurance
Dental insurance
401(k)
Tuition reimbursement
Paid time off
Employee assistance program
Vision insurance
401(k) matching
Professional development assistance
Life insurance

Qualifications

Vendor relationship building
Customer communication
Microsoft Outlook
Manufacturing
Manufacturing company experience

Full Job Description

1.0 PURPOSE

· To ensure organizational compliance with applicable regulatory requirements while managing and improving customer-facing quality processes. This position plays a critical role in maintaining product compliance, supporting regulatory submissions, and serving as the main point of contact for all customer quality concerns, complaints, and audits.

2.0 RESPONSIBILITIES/AUTHORITY

· Responsible for the development, maintenance, and oversight of regulatory and compliance programs.

· Contact person to interface directly with regulatory agencies and customers on matters related to compliance and product quality.

· Works with Quality Engineer as main point of contact for customer quality concerns for the purpose of working on, logging and tracking RCA activities.

· Manages and coordinates customer complaint resolution activities across departments assigning the person(s) responsible for root cause analysis (RCA).

· Manages customer audits and ensures timely and accurate follow-up on findings.

· Advises management on changes to regulatory requirements and their impact on products and operations.

· Ensures the company’s quality and environmental policies are implemented and the requirements of their ISO standards and regulations are met.

· Ensures that the company meets the FDA regulations and requirements as a manufacturer of components or medical devices.

· Ensures that regulations of export control compliance (ITAR and EAR) programs are implemented and are being followed.

· Identifies changes to regulations and next certifications the company should pursue to keep the organization at the forefront of customer requirements, or desired compliance.

· Leads or actively participates in continuous improvement initiatives aimed at enhancing operational efficiency, reducing waste, and driving productivity across the organization.

· Fosters and maintains strong, professional relationships with customers, vendors, and regulatory agencies to ensure alignment, trust, and compliance.

· Promotes a culture of continuous improvement by challenging existing processes and behaviors, encouraging innovation, and reinforcing accountability for enterprise-wide quality and performance excellence.

· Responsible for internal audit programs, training internal auditors, scheduling audits, reviewing reports and corrective actions.

3.0 DUTIES

Regulatory Affairs:

· Prepare, submit, and maintain regulatory filings.

· Management representative and monitor of global regulatory trends and ensure ongoing compliance with applicable standards (FDA, ISO 13485, etc.).

· Maintain and create up-to-date regulatory documentation and support internal/external audits and inspections.

· Collaborate and train product development and quality teams to define regulatory strategies for new and existing products.

· Track and report key quality metrics such as PPM, complaint trends, audit findings, and customer satisfaction indicators.

· Coordinate and host customer quality audits and follow through on required actions and documentation.

· Support the negotiation, review, and execution of customer quality agreements.

· Trains, coaches and mentors’ personnel to raise level of understanding of concepts related to regulatory compliance, quality, environmental systems, internal auditing, and good practices in documentation and manufacturing.

Customer Quality Management:

· Serve as the primary contact and coordinator for customer quality issues/complaints.

· Coordinate root cause analysis and implement CAPAs within the enterprise using cross functional teamwork to maintain high customer satisfaction ratings and implement effective corrective actions.

· Ensure that the documentation control process is implemented and followed by the organization.

· Promotes, leads and participates in quality and continuous improvement activities.

· Serves as liaison to external parties in matters related to quality systems and continuous improvement projects.

· Works with personnel at all levels to solve routine and special issues.

4.0 EDUCATION

· Bachelor of Science Degree preferably in Mechanical or Manufacturing Engineering. An Advanced Degree in related discipline a plus.

· Management and Problem-Solving Techniques courses such as: Certifications in Quality, Lean Manufacturing, Six Sigma, Technical Problem Solving or Root Cause Analysis.

· Training in compliance/regulatory programs a plus.

· Certified ISO 13485 Lead Auditor a plus.

5.0 EXPERIENCE

· 10 + years in management level regulatory or quality assurance roles in a manufacturing operation setting with a diverse well-rounded background.

· Minimum of 5 years in Quality administration or engineering role. Experience as Quality Manager and understanding of ISO Quality systems required.

· Knowledge of plastic injection molding processes related to medical devices a plus.

· Strong knowledge of safety procedures and policies a plus.

· Microsoft Office skills required (Excel, Word, PowerPoint, Outlook, etc).

6.0 PERSONAL CHARACTERISTICS

· Highly organized, a positive attitude with attention to detail.

· A highly self-motivated person.

· Willingness to learn and evolve skillsets.

· Excellent written and verbal communication skills.

· Strong interpersonal skills and a team builder.

7.0 REPORTING RELATIONSHIP

· President, Director of Engineering, Director of Operations

Pay: $75,000.00 - $90,000.00 per year

Benefits:

401(k)
401(k) matching
Dental insurance
Employee assistance program
Health insurance
Life insurance
Paid time off
Professional development assistance
Tuition reimbursement
Vision insurance

Work Location: In person

Quick Apply

Refine Your Search

affairs manager jobs in new haven, ct

Manager of Regulatory Affairs & Customer Quality

Specialty Business Manager, Derm - Stamford, CT

Medical Coding and Billing Assistant 1

Prin Regulatory Affairs Spec

Compliance Manager

Compliance Auditor

Sr. Associate Director, Professionalism and Leadership

Account Assistant 4

YM Compliance Educator

Program Manager, YSM Faculty Affairs

Assistant Vice President

Director, McDougal Graduate Student Center and Student Life

Coding and Billing Analyst

YM New Provider Auditor and Educator

Assistant Controller

Senior Administrative Assistant, Presidential Senior Fellowship Program

Program Manager, Research Affairs

Enrollment Management Specialist

Practical Nurse

Manager- Global CAPA System

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