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Regulatory Affairs Specialist
hace 3 semanas
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Lead and prepare RA meetings (regulatory status) involving the OU's under their responsibility. Plan timelines and registration strategies including initial submission, amendments, changes and any other regulatory activity for Latam, according to RA SSC Manager's and/or Sr. RAS instruction (if necessary).
Careers that Change Lives
We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Work with us to incentivize better patient care, and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.
Come strengthen your specialized skills and enhance your expertise. We’ll support you with the training, mentorship, guidance, and networks you need to advance, and empower you to work in the way that’s best for you. Together, we can confront the challenges that will change the face of healthcare. Join us for a career that changes lives.
Responsibilities may include the following and other duties may be assigned:
- Maintain ongoing dialogue with business partner(s) to develop strategies aligned with the business plan.
- Responsible for the timely completion of regulatory submissions and related amendments.
- Ensure all regulatory records/documents, including submissions, approvals, and amendments, are properly and adequately maintained in accordance with regulatory requirements and internal processes.
- Support or lead special Regulatory business projects and assignments as required.
- Collaborate regularly with the Marketing and Global Regulatory Team to assess and prioritize submissions to the country's Ministry of Health.
- Participate in product launch activities as required.
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
- Leads or compiles all materials required in submissions, license renewal and annual registrations.
- Recommends changes for labelling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Monitors and improves tracking / control systems.
- Keeps abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters.
Required Knowledge and Experience:
- Bachelor’s degree
- 2+ years of regulatory affairs related experience.
- Fluent in English level
- Experience working with regulations / Cofepris
- Experience in a regulatory affairs, either in regulatory product specialist, regulatory international or regulatory operations role.
- Effective project management skills
- Ability to create and work in cross-functional partnerships
- Effective negotiation skills
Nice to Haves:
- Regulatory Affairs Certification (desired)
- SAP experience
- Experience / use of PowerBI and Smartsheet
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.
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.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
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 90,000+ 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
