Find & Apply For Regulatory Affairs Manager Jobs in Watertown, Connecticut

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