Sr. Compliance Specialist
Sr. Compliance Specialist
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Job Description
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
Bring your talents to an industry leader in medical technology and healthcare solutions were a market leader and growing every day. You can be proud to part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We support your growth with the training mentorship and guidance you need to own your future success. Together we can transform healthcare.
Join us for a career in IT that changes lives.
Careers that Change Lives
A Day in the Life
POSITION RESPONSIBILITIES MAY INCLUDE THE FOLLOWING AND OTHER DUTIES MAY BE ASSIGNED:
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.
Provides Quality System support and guidance to maintain compliance with all FDA and international regulatory requirements
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
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) for the Operating Unit
Owns and drives Investigations Root Cause Analysis and resultant Corrective Actions and Preventive Actions
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.
Excellent writing and editing skills and computer skills.
Travel within US and International approximately 25% to off-site facilities to perform audits.
BASIC QUALIFICATIONS:
MUST HAVE: MINIMUM REQUIREMENTS:
EDUCATION REQUIRED:
Bachelors Degree
YEARS OF EXPERIENCE:
Minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years relevant experience
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.
NICE TO HAVE
2 or more years relevant experience in the manufacturing setting
Experience supporting and or participating in regulatory inspections and audits.
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.
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.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).
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
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.
Learn more about our business mission and our commitment to diversity here.
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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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 findhere 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.
Required Experience:
Senior IC
Employment Type
Full-Time
