Sr Compliance Specialist

Medtronic; North Haven (CT); On-site; USD 110,000 - 160,000; Full time

Job summary

Medtronic in North Haven, CT is seeking a QA Compliance professional to lead investigations, perform root cause analysis, and drive CAPAs. You will provide Quality System support to ensure FDA and ISO regulatory compliance, and oversee QMS programs across global sites.

The role requires extensive regulatory knowledge, strong communication, and the ability to coordinate audits, data analysis, and cross-functional collaboration with a focus on continuous improvement.

Qualifications

• Bachelor's degree required.
• Minimum 6 years of relevant experience, or 4 years with advanced degree.
• Knowledge of FDA, GMP, QSR, ISO 13485, and MDSAP for finished medical devices.
• Experience with Core QMS, Design Control & Manufacturing processes.
• Ability to analyze data and identify risks and root causes.
• Excellent written, oral communication and presentation skills.
• Ability to manage multiple critical projects.

Responsibilities

• Own and drive investigations, root cause analysis, and CAPAs.
• Provide Quality System support to maintain regulatory compliance.
• Oversee development and maintenance of quality systems, programs, processes, and procedures.
• Support EU Surgical Operating Unit with QMS setup, audits, and certifications.
• Partner with stakeholders to drive compliance program execution.
• Communicate business issues or opportunities to management.
• Lead audits per regulatory standards (FDA and equivalents).
• Perform trend analyses and report observations for improvement.
• Investigate and resolve compliance questions and complaints.
• Maintain knowledge of FDA, HIPAA and ISO requirements through policies.
• Demonstrate writing/editing skills in communications and reports.

Skills

Excellent writing and editing skills

Strong communication skills

Leadership abilities

Data analysis skills

Problem-solving skills

Regulatory knowledge

Education

Bachelor's Degree

Job description

We anticipate the application window for this opening will close on - 30 Oct 2026

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

• Own and drive Investigations, Root Cause Analysis and resultant Corrective Actions and Preventive Actions


• Provides Quality System support and guidance to maintain compliance with all FDA and international regulatory requirements


• Provide oversight for the development and maintenance of quality systems, programs, processes, and procedures to ensure ongoing compliance with Medtronic policies and global regulatory requirements.


• Supporting the EU Surgical Operating Unit entities from a Quality Oversight perspective consisting of pro-active support (example helping, supporting entities with setting up QMS processes, audits & certifications) & re-active support related to production quality issue resolution, PHO and FCA support)


• Partnering with and influencing internal and external stakeholders to drive needed change and the execution of compliance program.


• Responsible for communicating business-related issues or opportunities to next management level


• Lead, coordination and/or preparation of internal and external audits in accordance with regulatory standards (including FDA and its equivalents outside the US as well as other government regulatory agencies / authorities) for the Operating Unit


• Perform trend analyses and report compliance observations to identify areas in need of improvement


• Investigates and resolves compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc.


• Mastering knowledge of applicable Quality, FDA (Food & Drug Administration) Medical Device Directives/ Regulation, HIPPA (Healthcare Information Patient Privacy Act) and ISO (International Organization for Standardization) requirements through the updating of policies and procedures and acting as a liaison with appropriate policy experts.


• Excellent writing and editing skills, and computer skills.

Travel within US and International approximately 25%.

Basic Qualitifications:

• MUST HAVE: MINIMUM REQUIREMENTS:EDUCATION REQUIRED: Bachelor's Degree


• YEARS OF EXPERIENCE: Minimum of 6 years of relevant experience, or advanced degree with a minimum of 4 years relevant experience


• Demonstrated knowledge of all quality system elements and regulatory requirements (i.e. FDA, GMP, QSR and ISO 13485, and MDSAP) for finished medical devices with the ability to effectively implement and communicate those requirements in a government regulated healthcare industry. Special focus on Core QMS, Design Control & Manufacturing processes/requirements.


• Effective usage of data analysis tools, analytical and research skills, and problem-solving techniques with keen attention to detail and simultaneous understanding of the \"big picture\". Desire to follow an audit trail to identify risks, non-conformances, true root cause, etc.


• Outstanding written, oral communication, and presentation skills


• Sound judgement, ability to make decisions, work independently, and demonstrated leadership skills


• Ability to manage and execute on multiple critical projects simultaneously. Capable to manage multiple priorities and elevate issues.

NICE TO HAVE

• 3 or more years relevant experience in a Design & Development and/or Manufacturing setting


• Experience supporting and or participating in regulatory inspections and audits.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specif