Sr Regulatory Affairs Specialist
• 4+ years of medical device experience with experience in regulatory affairs or quality assurance with a Bachelor's degree
• Knowledge of Medical Device Quality Systems (21 CFR 820, ISO13483) and/or Pharmaceutical GMP (21 CFR 210/211).
• RAPS Certification (RAC)
• Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
• Experience with international standards (ISO, GHTF, ICH).
• Experience with FDA and international regulatory agency requirements, CE marking (AIMD and MDD).
• Experience with medical devices (510(k), PMA), pharmaceuticals, or combination products (drug/biologic-device).
• 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.
Physical job requirements:
• The employee is required to be independently mobile
• The employee is required to interact with a computer, and communicate with co-workers
The Vital Sync™ monitoring and CDS solution integrates information from wearable and bedside devices and transmits it to a hospital server. This single software platform helps clinicians gain more value from their medical devices. The Vital Sync™ CDS solution allows clinicians to take action with immediate access to smart, actionable data, implement clinical protocols through use of CDS apps, view patient physiological information remotely, and receive updates and alerts on any web-enabled device.
Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.
ABOUT MEDTRONIC:
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.
DISCLAIMER:
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.