Medtronic is an Equal Opportunity/Affirmative Action Employer
The Principal Regulatory affairs Specialist is responsible for formulating, communicating and applying regulatory promotional strategies by interpreting current FDA regulatory environment to ensure truthful and non-misleading communication to healthcare community, patients and the public. This position is also responsible for developing regulatory strategy, preparing U.S. and international submissions and obtaining approval to introduce Medtronic MiniMed products and therapies to markets worldwide.
Provide expert regulatory direction and oversight of promotional, advertising, educational and social media communication related activities.
Monitor and interpret latest FDA regulatory environment and assess impact to existing business procedures and practice.
Through the interpretation and application of relevant laws, regulations, guidelines, and company policies, help ensure compliance and compliant growth of the business by providing strategic and tactical regulatory support and addressing issues/opportunities with alternatives to achieve desired outcomes.
Partner with cross-functional teams to develop and maintain appropriate communication review procedures and systems/tools.
Participate in project meetings and provide feedbacks and on-going support to product development teams for regulatory issues and questions.
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 FDA 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.
Interact directly with FDA and/or indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.
Follow all work/quality procedures to ensure quality system compliance and high quality work.
May mentor or supervise other RAS, as directed by manager.
Performs other duties as assigned.
YEARS OF EXPERIENCE and EDUCATION REQUIRED:
7+ years regulatory experience with a Bachelor’s degree, or
5+ years regulatory experience with a Master’s degree
SPECIALIZED KNOWLEDGE REQUIRED:
Basic knowledge of FDA promotional practice laws, regulations, guidelines and enforcement trends
Knowledge of principles of engineering, physiology, pharmaceutical or medical device use
Experience reading, understanding and applying regulations to constantly change environment
Experience exercising appropriate discretion to prevent inappropriate disclosure of confidential information
Proficient computer skills; Microsoft office
Experience managing multiple projects & priorities
Regulatory Affairs Certification (RAC) preferred.
Advanced degree in scientific discipline
3+ of experience in regulatory review and approval of promotional, advertising, educational and social media communication materials. Familiarity with web-based social media communications (e.g., blogs, Facebook, Twitter).
7 + experience in developing regulatory strategies and preparing submissions (domestic and international) for Class II and Class III (FDA classification scheme) medical devices
Clinical or statistical experience
Strong Project management skills.
Effective interpersonal and negotiation/persuasion skills
Effective team member
Good analytical and critical thinking skills.
Must be results oriented and decisive. Failure to obtain results or arrive at appropriate decisions could result
Strong leadership and interpersonal skills including ability to effectively develop and present business information with leaders and employees at all levels of the organization
Excellent verbal and written communication skills with the ability to articulate complex ideas in easy to understand business terms.
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.
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.
While performing the duties of this job, the employee is regularly required to talk or hear, frequently required to sit and reach with hands and arms, and regularly required to stand; walk and use hands to finger, handle, or feel.
The employee must be able to travel domestically 10%
Medtronic - 13 months ago
Medtronic, Inc. is engaged in medical technology. The Company functions in seven operating segments that manufacture and sell device-based...