We anticipate the application window for this opening will close on - 23 May 2025

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

The Senior Principal Regulatory Affairs Specialist will play a key role in creating regulatory strategies and submissions to bring new robotic products to the global markets. This role will also work on expanding indications of existing products, as well as work on sustaining/post-market regulatory activities for Class II robotic devices. Devices that are part of the Robotics Surgical Technology Business are inclusive of hardware and software components. The senior principal specialist will work directly with new product development and sustaining teams to develop the global regulatory strategy and support regulatory activities throughout the product lifecycle. The senior principal specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide for Class II medical devices. This includes support of product changes to ensure that regulatory requirements continue to be met, documenting regulatory decisions, submissions to agencies, reviewing promotional materials, and ensuring that product technical documentation is current and accurate. Responsibilities are performed through the collaboration with various functions across the business unit, including but not limited to Regulatory Affairs, Research and Development, Clinical, Quality, and Marketing.
Responsibilities also include keeping senior management informed of the regulatory status of products and significant regulatory issues and maintaining proficiency in global regulatory requirements.
The successful candidate will be able to deal with advanced concepts and undefined paths, work independently, develop new and creative regulatory strategies and work collaboratively within the Regulatory department and other business functions. This position reports to the Regulatory Affairs Director.

Location: Strong preference to have a candidate work hybrid from Boston, MA / North Haven, CT / or Lafayette, CO. We can also consider candidates to work hybrid from another MDT site within the U.S.
Travel: Less than 15%

A Day in the Life / Responsibilities:
• Develop and support global regulatory strategies for Class I, and II devices and accessories for robotic surgical application.
• Be an active member of the product development core teams and responsible for identifying submission deliverables, timelines, and strategic direction. Reviews and approves technical documentation.
• Provide feedback and work with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies and provide ongoing support to product development teams to assure timely resolution to regulatory issues and questions.
• Prepare FDA IDE submissions, DeNovo/510(k) submissions, or EU submissions for new products and product changes as required.
• Directly communicates with regulatory authorities to resolve questions/issues that arise prior to and during product submissions or other pertinent issues.
• Participate in the product change assessments and define the regulatory impact of product changes in global markets.

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

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications.

SPECIALIST CAREER STREAM: Typically 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. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

DIFFERENTIATING FACTORS

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