Principal Regulatory Affairs Spec
Must Have Minimum Qualifications:
- Bachelor’s Degree in scientific discipline, advanced degree and RAC credential preferred
- 7-10 years’ experience in Regulatory Affairs
Nice to Have:
- Demonstrated experience in preparing 510(k) submissions for FDA, experience with Class III devices are a plus
- Demonstrated experience with submission to the European Union
- Excellent written and oral communication skills
- Computer literacy, proficiency in MS Word, Excel, PowerPoint, etc
- Excellent organizational and multi-project management skills and attention to detail
- Experience managing employees
- High Level of proficiency using MS Excel and MS Word.
- Working knowledge of MS Access, MS Project, and Adobe Acrobat Pro.
- High learning aptitude and adaptability with software systems
- Demonstrated technical writing skills.
- Multi-tasks and prioritizes effectively in fast-paced environment
- Highly organized, detail oriented, and efficient.
- Highly self-motivated
- Team player who seeks to help and learn from colleagues seeing the department success as their own
- A problem solver and critical thinker that relies on own judgment for appropriate level of decision making
- Ability to manage small scale projects to completion within and outside of the direct department.
- Demonstrated leadership qualities
- Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
- Proactively seeks to develop and become well-versed within in the regulatory landscape.
ORGANIZATIONAL RELATIONSHIPS/SCOPE:
- Works directly with the Director and/or Manager of Regulatory affairs on FDA and other Regulatory Affairs matters when required.
- Works with supervisors and managers during the course of registration preparation.
- Works with state personnel and foreign consulates/embassies personnel as appropriate.
- Works with project team members and other company personnel as required.
- Communicates with FDA regarding status of regulatory submissions and other regulatory matters
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
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.
The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EEO
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
