Associate Regulatory Affairs Specialist

Responsibilities may include the following and other duties may be assigned.

• Clinical
  • Collects, maintains, archives, and retrieves necessary source documents to ensure compliance with applicable SOPs and complete Scientific communication deliverables
  • Supports leadership in compiling necessary documents and other tasks during audits
  • Supports submission related activities which may include but not limited to CAP Agile upload and Veeva review/upload
  • Assist in the development and execution of meetings between internal and external cross-functional partners
  • Develops mechanisms for monitoring project progress and for intervention and problem-solving with leadership.
  • Assists in tracking and reporting on metrics related to medical writing and information deliverables services to leadership
• Regulatory Technical Communications
  • Creates, reviews, and reproduces text required for labeling medical products.
  • Ensures that labeling, art, film, and plate proofs meet all medical, legal, and regulatory requirements.
  • Monitors changes in labeling regulations in the US and/or abroad.
  • Reviews promotional and commercial communication material and ensures that it is supported by the data and consistent with the application.
  • Monitor, evaluate and recommend improvements to labeling processes, quality, systems tools, and/or policies.

SPECIALIST CAREER STREAM: An individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. Most of the time is spent delivering and overseeing the projects while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

DIFFERENTIATING FACTORS

Autonomy: Entry-level individual contributor on a project or work team. Works with close supervision.

Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects, or related activities.

Innovation and Complexity: Identifies, defines, and addresses problems that are not immediately evident but typically not difficult or complex.
Makes minor changes in systems and processes to solve problems.

Communication and Influence: Communicates primarily with internal contacts within immediate group.
Contacts others to gather, confirm and convey information.

Leadership and Talent Management: N / A job at this level is focused on self-development.

Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C. F. R. 214. 2(h)(4)(iii)(A), 2-4 years of experience required.

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain, restore health, and extend life unites a global team of 95, 000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here