Regulatory Affairs Manager - New Health Care Company

Collaborative customer relationships   

• Deep global regulatory experience   

• Operational excellence and strong cash flow   

• Strong sales growth and profitability with significant recurring sales   

​ 

​We expect the creation of the two companies will be completed by the end of 2023. For now, we will continue to operate as one global company. This role is positioned to drive the success of the "New Health Care Company”.   

The impact you will make in this role

As Regulatory Affairs Leader you will play a key role for bringing support to Regulatory Affairs Area in day-to-day activities for Health Care Business Group, in Brazil. In this role you will be able to Lead the regulatory affairs team in Brazil for the Spin Off process and maintain the Company in accomplishment with the local regulation and the Company polices. You will need to coordinate with your local team and the regulatory team in the Headquarter, Sources of Supplies, Quality, etc., the necessary regulatory information to compile, carry out the file preparation, coordinate the submission of dossiers with registration purposes, update registers, certifications, to ANVISA and INMETRO, guarantee the accomplishment and maintenance for local licenses and authorizations. At the same time will be required your regulatory support to business areas with documents, certificates for local bids and other regulatory requirements, support internal activities to support product commercialization, risk analysis/issue reviews and escalation. This role will be part of the new generation of the RAQ overlooking to support the Spin Off of Health Care Division as a new Healthcare company collaborating in providing various medical solutions with technological innovation in Brazil.

You will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

• Lead the local regulatory affairs team.

• Lead the regulatory process for Spin Off of Health Care business in Brazil.

• Interact with regional and global RA teams.

• Lead the interaction with other areas of local subsidiary.

• Represent SpinCo RA area in front of ANVISA and other regulators.

• Support the regulatory interaction with Medical Device association.

• Monitor with the team the maintenance of current sanitary registers, licenses and certifications and renewal these in a timely manner, before their expiration date.

• Support with the local team on regulatory activities for phase in – phase out products.

• Support with local team the leadership of new products registration.

• Lead the necessary regulatory changes and updates due to EU MDR processes, changes in IFU, packing, Legal Manufacturer, Physical Manufacturer, etc.

• You will be responsible to manage the local team of the compile, preparation, and support the submission of dossiers with regulatory purposes to ANVISA, other regulators and notify bodies.

• Support the local team about the development of Standard Operation Procedures (SOP’s) for Regulatory Activities and Tracking the activities assigned to your team.

• Labelling review, approvals and Advertising review for Marketing campaigns.

• Others: Approvals of Stocks Keeping Units (SKU’s) for Supply and Demand Activities for Brazil and others that your position and responsibility could be required.

Your Skills and Expertise   
To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications: 

• College: Degree on pharmaceutical, biochemical, medical or biomedical area.

• Registration on the class council.

• English, Advanced or Medium Level to perform in a fluid way all the activities assigned as part of a bilingual community across LATAM and International stakeholders (basic requirement as part of the job profile to fulfil to this position; skill to demonstrate during the interview).

• Experience iin regulatory affairs for medical devices in Brazil.    

• Advanced knowledge in Regulatory Affairs and Documentation Activities for Medical Devices

• Good understanding of the regulatory background in market authorization applications in Medical Devices.

Additional qualifications that could help you succeed even further in this role include: 

• Advanced skilled technical and leadership person

• Able to anticipate regulatory barriers based on their advanced knowledge of medical device regulations and uses challenges as learning opportunities to avoid making the same mistake twice.

• Strongest-proactive team player.

• Focuses work team to accomplish key strategic goals.

• Positively contributes to and supports team efforts and objectives.

• Provide strategic leadership to your team.

• Effective communications/negotiations with regulatory bodies.

• Capacity to negotiate with internal and external stakeholders.

• Must establish a capable and effective regulatory affairs team to ensure that objectives are achieved.

• Ability to coordinate multitasks.

• Analytic capacity, sense of urgency and prioritizing ability; proactivity and high effectiveness is required.

Work location: Hybrid

Relocation Assistance: No 

Must be legally authorized to work in country of employment without sponsorship for employment visa status (https://e.g., H1B status). 

Learn more about 3M’s creative solutions to the world’s problems at https://www.3M.com or on Twitter @https://3M.A 3M é um empregador que oferece oportunidades iguais à todos. A 3M não discriminará nenhum candidato baseado em sua raça, cor, idade, religião, gênero, orientação sexual, identidade ou expressão de gênero, nacionalidade ou deficiêhttps://ncia.Our approach to flexibility is called Work Your Way, which puts employees first and drives well-being in ways that enable 3M’s business and performance goals. You have flexibility in where and when work gets done. It all depends on where and when you can do your best work.

Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.

3M Global Terms of Use and Privacy Statement

Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at 3M are conditioned on your acceptance and compliance with these terms.

Please access the linked document by clicking here, select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with the terms.