Sr Regulatory Affairs Specialist – International
Careers That Change Lives
The Senior Regulatory Affairs Specialist – International is responsible for assisting with the development of strategies for worldwide governmental approval (with focus on OUS markets) to introduce new products to OUS market, maintain existing products, provide advice on regulatory requirements, prepares worldwide submissions and negotiates their approval with the agencies. In addition, this position also assists with the training of other regulatory affairs associates and provides work direction on international projects of large scale with significant business impact.
The Minimally Invasive Therapies Group (MITG) strives to enable earlier diagnosis, better treatment, faster complication free recovery, and enhanced patient outcomes through less invasive surgical solutions.
Respiratory, Gastrointestinal & Informatics (RGI) offers technologies to help with early detection and treatment of diseases and reduce complications to accelerate recovery from patient conditions. RGI focuses on expanding global access to therapies that improve clinical outcomes for gastrointestinal diseases and cancer, and patients with respiratory compromise. RGI also focuses on reducing complications through patient monitoring.
A Day in the Life / Responsibilities:
- Team with business unit Regulatory Affairs Specialists 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 international submissions for new products and product changes as required to ensure timely approvals for international 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 providing business project teams with country-specific requirements on labeling, applicable standards, product changes and documentation for changes requiring government approval, and supporting renewal activities as scheduled by international workplans.
- Review only significant submission decisions/content issues with manager.
- Interact 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, GMP audit, post-market vigilance reporting, product recalls, etc., as required by international regulatory agencies. – Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
- Support development of strategies and requirements, and communicate that information to business teams. – Provide feedback and on-going support to product development teams for international regulatory issues and questions.
- Ensure personal understanding of all quality policy/system items that are applicable to the position. Follow all work/ quality procedures to ensure quality system compliance and high-quality work.
Responsibilities may also include the following and other duties may be assigned.
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
- Leads or compiles all materials required in submissions, license renewal and annual registrations.
- Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Monitors and improves tracking / control systems.
- Keeps abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters.
- Recommends strategies for earliest possible approvals of clinical trials applications.
Must Have: Minimum Requirements
Bachelor’s degree with 4+ years of experience in regulatory affairs and/or the medical device industry OR Advanced degree with 2+ years of experience in regulatory affairs and/or the medical device industry.
Nice to Have:
- 5+ years medical device industry experience
- Experience with Class II/III medical devices (510(k), PMA, IDE)
- Experience working with medical device or pharmaceutical regulatory submissions
- Medtronic product development experience
- Clinical or statistical experience
- Experience with FDA and international regulatory agency requirements, ISO/GHTF standards
- Project management 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
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)
Learn more here
Job posted: 2020-07-09