Sr Regulatory Affairs Spec
- Bachelor’s degree and a minimum of 4 years of regulatory experience within the medical device, biotech, or pharmaceutical industries
- Or advanced degree and a minimum of 2 years of regulatory experience within the medical device, biotech, or pharmaceutical industries
Nice to Have
- Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and European Medical Device Regulation 2017/745
- Ability to work effectively on project teams.
- Must be able to manage multiple and competing priorities and manage programs with minimal oversight.
- Strong written, verbal, presentation, and organizational skills
- Strong analytical and problem-solving skills
- Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR, MDD), and other international geographies.
- Experience with medical device software requirements and software regulations.
- Ability to identify risk areas and escalate issues as appropriate.
- Prior direct involvement with product development teams
- Working knowledge of ISO 13485 and ISO 14971 standards
- Good understanding of product development process and design control through knowledge of US, EU & international medical device regulations
- Must be able to write clear, understandable technical documents, i.e. regulatory documentation and scientific presentations.
- Experience in assembling facts from various areas, analyzing data, and providing informed recommendations, as required.
- Demonstrate knowledge and skills in areas of regulatory pathways, risk-benefit analysis, and quality assurance internally and external with respect to submissions, registrations, obtaining approval/clearance, and post marketing compliance.
- Organized, efficient, process-oriented, high attention to detail.
- Effective interpersonal/communication skills
- Supporting products from initial concept through end-of-life phases
- Ability to effectively manage multiple projects and priorities.
- Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills.
- Works well under pressure in dynamic timeline-driven team and individual environments
- Regulatory Affairs Certification (RAC)
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 physical demands described within the Responsibilities 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
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. Learn more about our benefits here.
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here.
