Sr Regulatory Affairs Specialist
Must Have (Minimum Requirements):
• Bachelor’s degree and a minimum of 4 years of regulatory affairs experience in medical device, or advanced degree and a minimum of 2 years of regulatory affairs experience in medical device
Nice to Have (Preferred Qualifications):
• Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
• Experience in the preparation of 510(k) or PMA submissions for FDA and Technical Files for EU.
• Knowledge of FDA, EU, MHLW, Canada and TGA requirements
• Experience with international standards (ISO, GHTF, ICH).
• Experience in medical device acquisition due diligence
• Excellent interpersonal skills.
• Excellent oral and written communication skills.
• Proficient computer skills (email, word-processing and spreadsheet software).
• Good presentation skills.
• Must be able to handle multiple tasks/projects and manage priorities accordingly.
• Must have a high tolerance for ambiguity.
• Regulatory Affairs Certification
• Strong technical writing skills
• Ability to effectively manage multiple projects and priorities
• Proven ability to lead and work effectively in cross-functional teams
• Strong organization and time management skills
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)