Vacancy caducado!
Job Description:3M is establishing two industry-leading companies, creating value through the spin-off of its Health Care business, while 3M will continue to be a global material science leader, focusing our innovation to win in favorable global megatrends and attractive end markets. This new Health Care Company will be a leading global diversified health technology company with:
Proven category leadership
Exposure to attractive end-markets
Innovation mindset driving improved patient outcomes
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”.
This position provides an opportunity to transition from other private, public, government or military experience to a 3M career.The Impact You’ll Make in this RoleAs a Specialist Regulatory Affairs (m/f/), 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:
Managing compliance projects, developing and implementing of regulatory strategies and submissions for medical devices in Europe ,especially in Ukraine and Kazachstan.
Ensuring compliance with current national and European regulatory and standard requirements for market access and vigilance of medical devices.
Driving regulatory strategies during product development or product modification.
Creating, developing and maintaining of regulatory documents for European ( In particular Ukraine and Kasachstan) product submissions.
Supporting and further developing of the quality management system according to EN ISO 13485, EU MDR 2017/745 and MDSAP.
Communicating to authorities, notified bodies, consultants and distributors etc.
Processing of country-specific requests for marketing authorizations
Your Skills and Expertise To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications:
Engineering/scientific university degree (Master, Bachelor) or a comparable qualified education.
Experience in regulatory affairs and with quality management systems in the medical device or pharmaceutical industry.
Experience in European medical device regulations, especially Ukraine and Kazakhstan.
Good Ukrainian and Russian language skills, both written and verbal.
Additional qualifications that could help you succeed even further in this role include:
You have knowledge of European medical device regulations and quality management systems eg EN ISO 13485, EU MDR 2017/745, MDSAP, GMP, etc.
Ability to work in cross-functional and cross-cultural teams
Good communication and decision-making skills
Ability to negotiate with regulatory agencies and notified bodies
Ability to use databases and regulatory submission request tools eg MRS
Good English language skills, both written and verbal
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).Supporting Your Well-being 3M offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope. Chat with MaxFor assistance with searching through our current job openings or for more information about all things 3M, visit Max, our virtual recruiting assistant on 3M.com/careers. () At 3M, diversity & inclusion are essential to innovation. We seek and value differences in people! This Job ad is addressed to all potential candidates. As an equal opportunity employer 3M will not discriminate against any applicant for employment on the basis of religion, sex, sexual orientation, gender identity, national origin, age or disability.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. Our global Work Your Way initiative gives our employees flexibility in where and how their work can be performed, subject at all times to any location-specific rules and policies that may be in place from time to time (more information on such rules/policies can be provided upon request from the relevant in-location HR).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 (http://multimedia.3m.com/mws/media/1274940O/3m-jobs-country-data-privacy-statements-external.pdf) , 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.At 3M we apply science in collaborative ways to improve lives daily as our employees connect with customers all around the world. Learn more about 3M's creative solutions to global challenges at www.3M.com or on Twitter @3M or @3MNews.