Regulatory Affairs Analyst

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.

We are leaders in medical technology and solutions driven by a mission and built on a legacy of integrity and innovation. We are searching for a Regulatory Affairs Analyst to help improve patient care and collaborate across the industry to make healthcare more affordable and accessible. Be part of a community of experts committed to advancing high-quality cost-effective healthcare worldwide.

Come strengthen your specialized skills and enhance your experience. We will support you with the training mentorship guidance and networks you need to grow and empower you to work in ways that suit you best. Together we can take on the challenges that will transform the future of healthcare. Join us in building a career that changes lives. We are offering a flexible working arrangement with presence in our office in São Paulo Brazil.

Responsibilities may include the following and other duties may be assigned.

• 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 labeling 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.
• Recommends strategies for earliest possible approvals of clinical trials applications.

Required Knowledge and Experience:

• Bachelors degree in Pharmaceutical Chemistry Biomedical Engineering Medicine Chemical Engineering and practical experience in regulatory processes.
• Two to three years of relevant experience working in Regulatory Affairs within medical device companies in Brasil.
• Advanced English proficiency.
• Experience preparing/validating renewing and modifying Health Registrations.
• Experience working with government agencies such as Anvisa and Inmetro.

Experience with internal and external audits / CAPA (Corrective and Preventive Actions) is a plus as well as experience with Good Practice Certifications (GMP GDP) and ISO 13485.

We Offer

Medtronic is recognized by the Great Place to Work (GPTW) and in 2022 reached tenth place in the ranking of best companies to work for in the industry and services category. This recognition reinforces our ongoing commitment to the well-being of our employees. Our benefits are carefully designed to promote quality of life and this is why we work with the best suppliers on the market. Find out more about what we offer in our benefits package:

Private Pension Plan Transport voucher reimbursement for charter or parking Flexible meal voucher medical assistance and Dental assistance (for you and your legal dependents (spouses children and stepchildren) Life insurance Gympass childcare assistance pharmacy discount ESPP (discounted share purchase program) educational subsidy idiom program.

Wellness programs:

- Birthday Day Off

- Maternity leave 6 months Paternity leave 20 days

- Paid Family Leave Program of up to 6 weeks.

NOTE: OPTION of transportation hybrid work will not be available for positions in the clinical and sales areas as well as for positions that do not have working time control.

Our Commitment

Our unwavering commitment to inclusion diversity and equity (ID&E) means zero barriers to opportunity within Medtronic and a culture where all employees belong are respected and feel valued for who they are and the life experiences they contribute. We know equity starts beyond our workplace and we must play a role in addressing systemic inequities in our communities if we hope to have long-term sustainable impact. Anchored in our Mission we continue to drive ID&E forward both to enhance the well-being of Medtronic employees and to accelerate innovation that brings our lifesaving technologies to more people in more places around the world.

About Medtronic

Bold thinking. Bolder actions. We are 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 90000 passionate people. Powered by our diverse knowledge insatiable curiosity and desire to help all those who need it we deliver innovative technologies that transform the lives of two people every second every hour every day. Expect more from us as we empower insight-driven care experiences that put people first and better outcomes for our world.

In everything we do we are engineering the extraordinary.

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.

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).

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