Regulatory Affairs & Quality Assurance Engineer

Regulatory Affairs & Quality Assurance Engineer

Connection Technology Center (CTC) is seeking a Regulatory Affairs & Quality Assurance Engineer to lead regulatory compliance efforts while establishing and expanding CTC’s presence as a qualified vendor for our customers. This role is critical to ensure our products, systems, and processes meet applicable regulatory, quality, and contractual requirements across commercial, industrial, and government markets. This role offers an exciting opportunity to work in a dynamic and evolving field, collaborate with cross-functional teams, and contribute to the success and growth of our business. If you have a strong background in regulatory affairs, excellent communication skills, and a passion for driving regulatory excellence, we invite you to apply and become an integral part of our team.

About the Company

Connection Technology Center (CTC) is the global leader in the design & manufacture of cutting-edge vibration analysis hardware for machine condition monitoring. As a family-owned & operated business for 30 years, we are proud to play a crucial role in preventing operational disruptions, financial losses, and safety concerns for heavy industry. From small scale manufacturing to Fortune 500 companies in Paper & Pulp, Auto & Steel, Food & Beverage, Pharmaceutical, Mining and many more, our mission is to create products that help ensure seamless operational uptime and contribute to a safer, more efficient manufacturing future.

Main Responsibilities

Regulatory Strategy Development:

o  Formulate and execute regulatory strategies to support the approval and ongoing compliance of all products.

o  Collaborate with internal teams to ensure regulatory requirements are considered in product development plans.

Regulatory Compliance:

o  Stay abreast of relevant regulatory requirements (including but not limited to ISO9001 and hazardous locations standards) and ensure the organization's compliance with local, national, and international regulations.

o  Interact with regulatory agencies and authorities to address inquiries and facilitate inspections.

o  Perform and oversee internal and external audits

o  Provide guidance to internal teams on regulatory matters, including labeling, advertising, and promotional materials.

Government Contracts & Vendor Readiness:

o  Lead efforts to establish CTC as a qualified vendor, including registrations, certifications, and compliance frameworks.

o  Manage and maintain required vendor portals, databases, and agency-specific requirements if needed.

o  Drive certification initiatives needed for:

o  AS9100

o  Quality, safety, and manufacturing-related certifications

Communication with Regulatory Agencies:

o  Serve as the primary point of contact with regulatory agencies.

o  Respond to regulatory inquiries and facilitate interactions during regulatory inspections.

Cross-Functional Collaboration:

o  Work closely with R&D, Continuous Improvement/Quality Assurance, and other departments to integrate regulatory considerations into all aspects of product development.

Requirements

·       Bachelor’s degree in relevant field required.

·       4-6 years’ experience in regulatory affairs.

Knowledge, Skills, and Abilities

·       Ability to lead toward achieving regulatory objectives.

·       Strong ethical judgment and decision-making skills.

·       In-depth knowledge of regulatory requirements and industry best practices.

o  Preferred: understanding of ATEX, IECEx, and CSA standards for intrinsically safe products as well as experience managing ISO certifications.

·       Excellent analytical and problem-solving skills.

·       Effective communication and interpersonal skills.

·       Strong project management, leadership, and team-building skills.

·       Detail-orientated with a commitment to maintaining high standards.

·       Must be able to work individually as well as in a small team environment.

Work Location

This in-person position will work out of the Victor, NY facility.

Salary Range:

$80K - $100K / yr

Benefits

• Health Insurance
• Dental Insurance
• Vacation Time
• Sick Leave
• 401K plan with Employer Match
• Summer golf membership to Bristol Harbour Private Golf Course 

How to Apply

Please apply here: https://www.ctconline.com/opportunities/employment/

Connection Technology Center (CTC) is an equal-opportunity employer. NYS law prohibits discrimination because of age, race, creed, color, national origin, sexual orientation, military status, sex, disability, predisposing genetic characteristics, marital status, domestic violence victim status, carrier status, gender identity, prior conviction records, prior arrests, youthful offender adjudications or sealed records unless based upon bona fide occupational qualification or other exception, or any other protected characteristic as outlined by federal, state, or local laws.