Regulatory Affairs Specialist
Share
Job Location:
Monthly Salary:
Posted on:
11 hours ago
Vacancies:
1 Vacancy
Job Summary
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.
A Day in the Life
Take on a pivotal role as a Regulatory Affairs Specialist in Spain supporting both pre-market and post-market regulatory activities within Medtronics Diabetes spin-off this role you will be a key partner to cross-functional teams ensuring regulatory compliance across the product lifecycle while enabling timely market access and sustaining ongoing business operations. This is an exciting opportunity to contribute to a growing agile organization focused on innovation and delivering impactful solutions for people living with diabetes.This position is an exciting opportunity to work with Medtronics Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential enabling us to operate with greater speed and agility. As a separate entity we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
Responsibilities may include the following and other duties may be assigned:
- Direct or performs coordination and preparation of document packages for regulatory submissions from all areas of company internal audits and inspections.
- Compile all materials required in submissions license renewal and annual registrations.
- Execute changes for labelling manufacturing marketing and clinical protocol for regulatory compliance.
- Monitor and improve tracking as well as control systems.
- Keep abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters.
- Implement strategies for earliest possible approvals of clinical trials applications.
Required Knowledge and Experience:
- Bachelors degree in Life Sciences Engineering Chemistry or related technical field
- 2-4 years of medical device regulatory experience tied to submissions processes within the Spanish Market with strong knowledge of AEMPS system and understanding of EU MDR compliance.
- Proficiency in Spanish (mandatory for interaction with Spanish Competent Authorities) and English (business language)
- Experience working within ISO 13485 Quality Management Systems requirements risk management (ISO 14971 EN 14971) with good understanding of AEMPS system for medical device registration clinical evaluation post-market surveillance processes and EUDAMED.
- Other competence include Field Safety Corrective Actions (FSCA) support while also possessing expertise in hosting or supporting regulatory audits.
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.
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 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
Required Experience:
IC
Key Skills
- Athletics
- Corporate Banking
- Dreamweaver
- Facilities
- IT Support
About Company
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 excit ... View more
