Senior Regulatory Affairs Manager - Mervue

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.

As the Senior Manager of Regulatory Affairs, you play a key leadership role within the Acute Care & Monitoring (ACM) operating unit, supporting regulatory activities for a portfolio of products.

This role entails implementing regulatory strategies, managing regulatory submissions, assessing the regulatory impact of product changes, and ensuring your team delivers high-quality results through providing guidance and mentorship to team members, supporting their development and helping them navigate complex regulatory requirements.

Collaborate closely with cross-functional partners such as R&D, clinical, operations, and marketing to ensure regulatory needs are integrated into product development and lifecycle management. Occasionally represent the company in discussions with regulatory bodies and industry groups, supporting regulatory compliance and business objectives supporting Acute Care & Monitoring achieve regulatory success and maintain a competitive edge.

• Regulatory Strategy & Product Development: Support the development and implementation of global regulatory strategies throughout the product lifecycle, from R&D through commercialization and post-market activities. Collaborate with cross-functional teams to ensure regulatory requirements are incorporated into development plans and timelines. Provide regulatory guidance on product submissions (e.g., 510(k), etc.)
• Market Access & Submissions: Oversee the preparation, review and submission of regulatory filings in the US and EU. Liaise with regulatory bodies (e.g., FDA, Notified Body) to facilitate product approvals and resolve regulatory issues as needed
• Team Leadership & Development: Manage resources across assigned product programs, aligning activities with departmental priorities. Support team structure, talent development, and professional growth of regulatory staff. Mentor and coach team members to build regulatory expertise.
• Risk Management & Compliance: Identify potential regulatory risks and contribute to the development of mitigation strategies. Stay informed on evolving regulatory trends and changes, providing timely guidance to teams
• Business Initiatives: Participate in business initiatives by providing regulatory input and supporting due diligence for new ventures and partnerships.

• Level 8 Degree in Scientific or Engineering field with a minimum 7 year’s experience in regulatory affairs for medical devices of which 5+ years had leadership experience as demonstrated through direct  management and/or mentorship/advisory capacity or an advanced degree with a minimum of 5+ year’s experience in regulatory affairs for medical devices with 5+ years had leadership experience as demonstrated through direct  management and/or mentorship/advisory capacity direct management and/or mentorship/advisory capacity
• Leadership: Experience in a regulatory affairs leadership role, with a record of managing teams and supporting departmental goals
• Regulatory Affairs: Strong knowledge of the global regulatory landscape and experience interacting with regulatory bodies
• Product Lifecycle: Experience supporting medical devices from concept to market, including post-market activities
• Business Acumen: Understanding of business operations and financial considerations within a regulated environment
• Process Excellence: Proven ability to support process improvements and change management initiatives
• Data & Analytics: Ability to use data and analytics to support decision-making and communicate regulatory requirements
• Communication & Influence: Excellent communication and interpersonal skills, with the ability to collaborate across functions and represent the department externally

Medtronic offer a competitive salary and flexible Benefits Package

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Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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