Senior Regulatory Affairs Specialist

Company: Medtronic GmbH
Location: Mansfield
Posted on: February 23, 2021

Job Description:

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 Medtronic is seeking a Senior Regulatory Affairs Specialist to support the Hernia and Wound Management Regulatory Affairs team. The selected candidate will provide regulatory support on a range of medical devices focusing on implantable Hernia Mesh and a diverse line of Sutures (absorbable/non-absorbable, coated/uncoated). Regulatory support will include change development projects, change assessment, domestic submissions, international submissions, commercial support, manufacturing support, compliance related activities, systems improvement, and other responsibilities aligned with global medical device regulations and the goals of the Hernia and Wound Management business. A Day In The Life The Senior Regulatory Affairs Specialist is responsible for the support of new product development and maintenance of business projects. Specific activities include but are not limited to:

• -- Lead the preparation, submission, and maintenance of global product registrations with a focus on 510(k), Technical Documentation, and STED
• Collaborate with internal Medtronic international regulatory departments to assess international registration requirements, develop international regulatory strategy, and ensure timely execution
• Review design control documents including documents associated with design inputs and design outputs
• Review product labeling for compliance with global labeling regulations
• Review advertising and promotional literature for compliance with applicable regulations
• Interpret and evaluate proposed regulations and advise on impact of such regulations on the business
• Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies Must Have; Minimum Requirements
  • Bachelor's Degree in a scientific discipline
  • Minimum 4 years Regulatory Affairs experience in the Medical Device industry or minimum 2 years regulatory affairs experience in the Medical Device industry with an advanced degree. Nice To Have
    • Advanced degree in Regulatory Affair or RAC certificate
    • Proficiency in US and Europe medical device regulations
    • Strong organizational skills
    • Ability to manage multiple projects
    • Deadline conscious
    • Problem solving skills
    • Team oriented
    • Strong oral and written communication skills
    • Fluent in local language required
      
      
      About Medtronic
      
      
      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) It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here .

Keywords: Medtronic GmbH, Fort Smith , Senior Regulatory Affairs Specialist, Other , Mansfield, Arkansas