Prin Regulatory Affairs Spec Global Harmonization
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Monthly Salary:
Posted on:
10 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
This role serves as a key driver of Medtronics global regulatory advocacy and policy strategy with a primary focus on advancing global harmonization of medical device regulations. The individual partners closely with regional and cross functional experts to monitor interpret and influence evolving regulatory policies develop enterprise advocacy positions and high quality materials and lead coordinated engagement with regulators and industry groups worldwide. Operating in a fast paced highly matrixed and global environment the role translates complex regulatory issues into clear guidance and targeted actions that support timely patient access to safe effective and innovative medical technologies.Responsibilities may include the following and other duties may be assigned:
- Define align and execute global regulatory advocacy strategies in partnership with regional and functional SMEs with emphasis on global harmonization
- Develop and lead high-quality advocacy materials (white papers talking points presentations) and coordinate enterprise-wide input and alignment
- Lead external commenting on regulations and guidances; participate in industry working groups and engage with regulators and associations as directed
- Establish and manage internal working groups tools playbooks and training to enable coordinated globally harmonized advocacy
- Monitor global regulatory trends and emerging issues translate enterprise strategy into targeted regional actions and maintain advocacy trackers and SharePoint resources
Required Knowledge and Experience:
- Bachelors Degree
- Five to seven years of experience in regulatory advocacy and influencing healthcare policy in a global matrixed environment.
- Strong understanding of international medical device regulations guidelines and regulatory policy frameworks.
- Technical regulatory knowledge across key areas such as postmarket surveillance MDSAP clinical evidence and/or human factors.
- Excellent written verbal and visual communication skills to synthesize complex regulatory concepts into clear persuasive materials
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
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
