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1+ months

Sr Compliance Specialist

Boulder, CO 80305
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Sr Compliance Specialist


Boulder, Colorado, United States

Requisition #:


Post Date:

Dec 17, 2021

**Careers that Change Lives**

**A Day in the Life**


+ Provide guidance to Design Assurance engineering activities in support of sites Product Development and Life Cycle processes including design controls, quality planning, risk assessments/analysis/management, design reviews, test method development and validation, design and process verification and validation test plans and reports, post-market monitoring, investigations, follow-up and reporting

+ Ensure that Design controls are compliant withall relevant regulations (FDA, 13485, PMDA).

+ Provide feedback to corrective and preventative actions to Design Assurance teams

+ Support DMR and DHF compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained

+ Implements policies and procedures to ensure that appropriate statutes and regulations and ensures that regulatory reporting requirements are met

+ Ensures alignment with legal and ethical standards of the organization

+ Provide Quality Systems compliance support and guidance to maintain compliance with all FDA, and other U.S., and international regulatory requirements

+ Assists in developing Compliance training programs that focus on the elements of a companywide compliance program.

+ Manage and drive accountability in alignment with business goals and initiatives

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

+ Performs the coordination and/or preparation of internal and external audits in accordance with regulatory standards (includes FDA and its equivalents outside the US as well as other government regulatory agencies / authorities)

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

+ Acts as a subject matter expert for quality audits and, as such, maintains a comprehensive knowledge of FDA, MDD, and ISO 13485 quality requirements and their interpretation, along with knowledge of international standards and requirements

+ Travel within US and International approximately 25% to off-site facilities to perform audits.

**Must Have: Minimum Requirements**

+ Bachelors degree required

+ Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience


+ 2 or more years relevant experience in the manufacturing setting

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

+ Certified Lead Auditor from a recognized professional organization or an accrediting organization per a Quality Management System schema or standard.

+ 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 Design Control 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, demonstrated leadership skills

+ Ability to manage and execute on multiple critical projects simultaneously.

+ Capable to manage multiple priorities and escalate issues.

**About Medtronic**

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.

**Physical Job Requirements**

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. (ADA-United States of America)
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.


Posted: 2022-03-08 Expires: 2022-06-06
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Sr Compliance Specialist

Boulder, CO 80305

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