Senior Regulatory Operations Specialist - Global Services at Medtronic in Mansfield, Massachusetts

Job Description:

SENIOR REGULATORY OPERATIONS SPECIALIST

The mission of Global Regulatory Affairs is to influence the regulatory environment, develop innovative strategies for regulatory approval and post-introduction requirements, and anticipate and respond to changing requirements in order to benefit the patients we serve.

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It's no accident -we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

Careers That Change Lives

The Senior Regulatory Operations Specialist will support enterprise wide quality system management activities across regulatory affairs. Sitting in the newly created Global Regulatory Shared Service team, the senior regulatory operations specialist will be a key team member responsible for change control activities, managing procedure release planning for enterprise RA processes, developing process improvement plans, participate in audits and CAPA activities.

The successful candidate will:

• Have a strong background with quality systems
• Have experience with documentation releases through a document management system
• Have experience supporting internal and external inspections
• Work cross-functionally and in a matrixed environment
• Have experience with continuous improvement activities
• Experience with Agile or other document management systems

A Day in the Life

• Manage change control activities for global regulatory procedures.
• Initiates special projects with minimal direction from manager including collecting and analyzing data, and presenting results
• Manage project status reports for QMS harmonization efforts across various regulatory workstreams
• Participate in audits and CAPA activities.
• Mentor and direct colleagues in achieving department objectives and in compliance with policies and procedures.

Must Have; Minimum Requirements

• Bachelor's Degree
• Minimum 4 years of process improvement work experience in the medical device field with Bachelor's degree.
• OR minimum 2 years of process improvement work experience in the medical device field with an advanced degree.

• Strong project management skills.
• Proven ability to work globally.
• Self-motivated, entrepreneurial, independent, driven individual to meet objectives.
• Excellent written and oral communication skills.
• Ability to think strategically and execute methodically.
• Ability to quickly learn new computer technology software packages with minimal training
• Ability to work effectively within a matrix environment
• Ability to multitask and prioritize while managing multiple projects and day to day responsibilities
• Ability to influence cross-functional teams without formal authority.
• Strong attention to detail and an ability to deal with ambiguity

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)

Additional Information

• Posting Date: May 13, 2021
• Travel: No