Regulatory Affairs Manager at Medtronic Massachusetts

Regulatory Affairs Manager Job at Medtronic, Massachusetts
Medtronic seeks a Regulatory Affairs Manager to oversee product approval strategies and compliance for Lung Health and Gynecologic devices. The role involves leading a regulatory team, developing submission strategies for U.S. and EU markets, and collaborating across functions to support product lifecycles.
Oversee daily operations of Lung Health and Gynecologic Regulatory Affairs team
Develop and execute regulatory strategies for existing, new, and modified medical devices
Lead interactions with regulatory agencies and manage submission preparation and coordination
Manage team performance, resource planning, talent development, and succession planning
Partner with quality, engineering, clinical, and commercial teams to ensure compliance throughout product lifecycle

Bachelor's degree required; advanced degree with 5+ years experience acceptable
Minimum 7 years relevant regulatory affairs experience
Knowledge of U.S., EU MDR, and international medical device regulations
Experience with FDA interactions, Q-Submissions, and regulatory agency meetings
Demonstrated ability to lead high-performing teams and develop talent
Strong project management and cross-functional collaboration skills

ServiceNow -ServiceNow IT/OT Asset Management (ITAM) - Manager - Tech Cons - Open Location Job at Ernst & Young
...build a better working world. In the digital economy, it takes more than good ideas and... ...decision-making. As a ServiceNow Consulting Manager youll play a leading role in that... ...working to improve our customers IT/OM Asset Management process or evaluating how AI can...

Automotive General Manager - Philpott Hyundai Job at Sonic Automotive
...At a Sonic Automotive family dealership, you'll find the opportunities, resources, and support you need to grow and develop professionally... ...: $250K - $350K Annually Job Description The General Manager is fully accountable for the overall success and smooth...

Rumble Boxing Trainer / Coach Job at Rumble - Staten Island
...trainers to lead, instruct, and motivate. Our 45-minute class is a full-body workout designed around our water-filled, tear-drop-style boxing bags. RUMBLE QUALITIES : Customer-Service Skills. Rumble trainers have a unique/fun energy and establish/maintain...

Sr. Financial Analyst - Contract Job at Finalsite
Summary: We are engaging a highly analytical, business-minded Sr. Financial Analyst on an independent contractor basis to support our... ...Remote - Anywhere within the US RESPONSIBILITIES Financial Planning & Analysis Support monthly, quarterly, and annual...

Junior Data Scientist/Engineer - Bloomington Job at SynergisticIT
...,000 - 154,000 per year Requirements: Recent graduates in Computer Science, Engineering, Mathematics, or Statistics with limited... ...Responsibilities: Connect candidates with employers actively seeking entry-level talent Provide end-to-end job placement assistance to...