Sr Regulatory Affairs Specialist Patient Monitoring
MINIMUM REQUIRED QUALIFICATIONS (MUST BE EVIDENT ON YOUR RESUME):
• Bachelor's Degree
• 4+ years of Quality Assurance or Regulatory Affairs experience in medical device with Bachelor’s Degree.
• Knowledge of Medical Device Quality Systems (21 CFR 820, ISO13483) and/or Pharmaceutical GMP (21 CFR 210/211).
• Experience with international standards (ISO, GHTF, ICH).
• Experience with FDA and international regulatory agency requirements, CE marking (MDR and MDD).
• Experience with medical devices (510(k))
• Experience working with cross-functional teams.
• Experience working with technical documentation.
• Project management skills.
• Product development experience.
• Knowledge of Medtronic procedures and systems.
• Knowledge of the business goals, products, therapy, customer needs, reimbursement, and competitive environment.
• Strong oral and written communication skills.
• Effective interpersonal skills.
• Effective team member.
• Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
• Ability to effectively manage multiple projects and priorities.
• Proficient skills with MS Word, MS Outlook, MS Excel.
• 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.
• Must be able to travel independently to various Medtronic buildings/sites.
• Must be able to travel by plane and by car.(<10%) No travel required during the COVID-19 crisis
• Bachelor's Degree
• 4+ years of Quality Assurance or Regulatory Affairs experience in medical device with Bachelor’s Degree.
• Knowledge of Medical Device Quality Systems (21 CFR 820, ISO13483) and/or Pharmaceutical GMP (21 CFR 210/211).
• Experience with international standards (ISO, GHTF, ICH).
• Experience with FDA and international regulatory agency requirements, CE marking (MDR and MDD).
• Experience with medical devices (510(k))
• Experience working with cross-functional teams.
• Experience working with technical documentation.
• Project management skills.
• Product development experience.
• Knowledge of Medtronic procedures and systems.
• Knowledge of the business goals, products, therapy, customer needs, reimbursement, and competitive environment.
• Strong oral and written communication skills.
• Effective interpersonal skills.
• Effective team member.
• Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
• Ability to effectively manage multiple projects and priorities.
• Proficient skills with MS Word, MS Outlook, MS Excel.
• 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.
• Must be able to travel independently to various Medtronic buildings/sites.
• Must be able to travel by plane and by car.(<10%) No travel required during the COVID-19 crisis
• Bachelor's Degree
• 4+ years of Quality Assurance or Regulatory Affairs experience in medical device with Bachelor’s Degree.
• Knowledge of Medical Device Quality Systems (21 CFR 820, ISO13483) and/or Pharmaceutical GMP (21 CFR 210/211).
• Experience with international standards (ISO, GHTF, ICH).
• Experience with FDA and international regulatory agency requirements, CE marking (MDR and MDD).
• Experience with medical devices (510(k))
• Experience working with cross-functional teams.
• Experience working with technical documentation.
• Project management skills.
• Product development experience.
• Knowledge of Medtronic procedures and systems.
• Knowledge of the business goals, products, therapy, customer needs, reimbursement, and competitive environment.
• Strong oral and written communication skills.
• Effective interpersonal skills.
• Effective team member.
• Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
• Ability to effectively manage multiple projects and priorities.
• Proficient skills with MS Word, MS Outlook, MS Excel.
• 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.
• Must be able to travel independently to various Medtronic buildings/sites.
• Must be able to travel by plane and by car.(<10%) No travel required during the COVID-19 crisis
MITG
The Minimally Invasive Therapies Group (MITG) strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions
RESPIRATORY, GASTROINTESTINAL & INFORMATICS (RGI) offers a complete line of solutions that spans the continuum of care. We help with early detection and treatment of diseases and reduce complications to accelerate recovery from patient conditions. We focus on expanding global access to our therapies that improve clinical outcomes for gastrointestinal diseases and cancer, and patients with respiratory compromise.
This is a cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe
Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.
Medtronic is a $30.5 Billion company with 90,000+ employees in more than 160 countries.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
EEO STATEMENT:
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.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.