Medtronic is an Equal Opportunity/Affirmative Action Employer
The Principal Regulatory Affairs Specialist will join the global drug-eluting balloon team to lead and support regulatory approval of this innovative provides and often leads regulatory support for new and existing products class III combination device in both the U.S. and international markets. Implements worldwide regulatory plans. The position typically will reports to the Regulatory Affairs Manager/Director.
Regularly communicates effectively with senior management and regulatory agencies in a manner that supports approval and other key company goals/objectives; and interfaces among the regulatory function, the business unit, and other businesses and geographies.
Establish a strong and interactive working relationship with regulatory agencies, geography RA specialist and other functions.
Significant regulatory knowledge in pre- and post-market submissions, products, and geography regulations.
Plays a leadership role in effectively planning and driving successful completion of complex cross-functional projects.
Develops strategies that leverage opportunities and experiences across functions. Influence and inspire alignment with business goals, internally and externally.
Review and approve Document Change Orders (COs) for regulatory department.
Maintain technical knowledge of devices in area of responsibility.
Maintain strong understanding of product lines/disease states and customers.
Maintain strong understanding of product distribution release processes and geography launch/maintenance requirements.
Participate in department systems development initiatives.
Work with Regulatory Affairs staff, engineers, and technical experts to resolve questions and issues of moderate scope and complexity.
Support the full quality system and cross-functional roles in the PDP.
Effectively communicate project plans, status and resource requirements to both core teams and senior management.
Mentor and teach less experienced Regulatory Affairs Specialists.
Bachelor’s degree in Engineering, Regulatory Science, Business, Life Sciences, or related technical field.
Years of Experience:
7+ years w/ Bachelor’s degree or 5+ years w/ Master’s degree experience in Regulatory Affairs, Engineering, Quality or related Technical field.
Experience with drug combination products.
Specialized Knowledge Required:
Working knowledge of global medical device regulations, including submissions.
Demonstrated advanced writing/technical writing skills.
Demonstrated Microsoft Word, Excel and Adobe software skills.
Experience in or exposure to combination devices.
Experience in or exposure to pharmaceutical regulations.
Experience with leading cross-functional teams.
Experience working with technical documentation.
Superior verbal and written communication skills.
Superior organizational skills.
Experience with solving often complex problems and concerns.
Attention to detail.
Effective negotiating skills.
Proficient with project management and adherence to time schedules.
Quality or Regulatory compliance experience or background.
Demonstrated writing/technical writing skills.
Self-motived and energetic.
Work well under pressure in a dynamic environment.
Ability to audit own work and work of others to ensure compliance.
Solid understanding of annual planning process.
Demonstrated influence skills.
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.
Medtronic, Inc. is engaged in medical technology. The Company functions in seven operating segments that manufacture and sell device-based...