Sr Compliance Specialist

BioCT Innovation Commons; North Haven (CT); Presencial; USD 90.000 - 134.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health, Dental and Vision Insurance

401(k) with employer match

Paid Time Off

Tuition assistance

Descripción de la vacante

Medtronic in North Haven, CT is seeking a Senior Quality & Regulatory professional to lead investigations, root-cause analysis, and corrective actions across global medical device compliance programs. You will provide Quality System support, oversee audits, and ensure adherence to FDA, ISO 13485, GMP, and MDSAP standards while coordinating with global stakeholders.

The role requires strong communication, data analysis, and project leadership, with travel up to 25% and a focus on continuous

Formación

• Knowledge of FDA, GMP, QSR and ISO 13485, and MDSAP requirements.
• Experience implementing and communicating regulatory requirements in healthcare.
• Experience leading audits and maintaining quality systems.

Responsabilidades

• Own investigations, root cause analyses and corrective actions.
• Provide Quality System support to ensure regulatory compliance.
• Lead and/or participate in internal and external audits.
• Support regulatory inspections and audits across entities.
• Perform trend analyses and communicate improvements.
• Coordinate with stakeholders to drive compliance initiatives.

Conocimientos

Root cause analysis

Regulatory compliance

Quality investigations

Data analysis

Audits & inspections

Leadership

Communication

Educación

Bachelor’s degree

Advanced degree

Descripción del empleo

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 specific to each role.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$89,600.00 - $134,400.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
• Paid sick time
• Employee Stock Purchase Plan

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below: Medtronic benefits and compensation plans

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.