Senior Regulatory Affairs Specialist
- Define the regulatory strategy and manage regulatory submission activities for complex product development activities and product maintenance for existing approved products.
- Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staffs to provide regulatory support for new products/therapies and changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
- Prepare regulatory (eg, FDA/Notified Body) submissions for new products and product changes, as required, to ensure timely approvals for clinical studies and market release. Review significant product submissions with manager and negotiate submission issues with agency personnel.
- Provide support to currently marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval.
- Interact directly with FDA/Notified Body and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.
- Support regulatory compliance activities, including manufacturing site registration, audits, etc., as needed.
- Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
- Provide business and product information to international regulatory staffs to enable development of strategies and requirements and communicate that information to business teams.
- Provide feedback and on-going support to product development teams for regulatory issues and questions.
- Ensure personal understanding of all quality policy/system items that are personally applicable.
- Follow all work/quality procedures to ensure quality system compliance and high-quality work.
- Bachelor’s degree
- Minimum 4 years of experience in regulatory affairs or the medical device industry with Bachelor’s degree OR
- Minimum 2 years of experience in regulatory affairs, or the medical device industry with an advanced degree
- Experience working with medical device or pharmaceutical regulatory submissions
- 4+ years medical device industry experience.
- Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
- Effective interpersonal skills.
- Effective team member.
- Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
- Ability to effectively manage multiple projects and priorities.
- Proficient computer skills.
- Experience with 510(k)/IDE/PMA device product submissions and other worldwide submissions and clearances.
- Experience performing advertising and promotion reviews for medical devices.
- Experience with FDA and international regulatory agency requirements
- Project management skills.
- Excellent oral and written skills.
- Excellent analytical thinking skills.
- 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 by phone and in-person with peers and co-workers.
- Must be able to travel independently to various Medtronic buildings/sites or FDA locations.
- Must be able to travel by plane and by car.(<10%)
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)
Job posted: 2020-04-30