Senior Regulatory Affairs Specialist - Global Submissions
Integer Holdings Corporation
Integer Holdings Corporation in Plymouth, MN is looking for a Regulatory Affairs Specialist III to oversee compliance and regulatory submissions for medical devices. In this role, you'll support the Regulatory Affairs management team and ensure adherence to national and international regulations. The ideal candidate will have a bachelor's degree, 3+ years of experience in Regulatory Affairs, and a strong understanding of FDA regulations. This position offers a competitive salary and a comprehensive benefits package. #J-18808-Ljbffr
- ...Holdings in Plymouth, Minnesota, is seeking a dedicated Regulatory Affairs Specialist to support compliance efforts for medical devices. You will... ...work closely with the Regulatory Affairs team to prepare submissions and manage regulatory files while adhering to company...Senior
- ...A leading global healthcare technology company is seeking a Regulatory Affairs Specialist in Minneapolis, MN to manage regulatory submissions for medical devices. The candidate should have experience in Class II and III devices and a strong understanding of FDA and EU...Suggested
- ...Stratasys is seeking a Sr. Import/Export Analyst to support global trade operations by ensuring compliance with import/export regulations. You will prepare and maintain documentation, coordinate international shipments, and analyze trade data for compliance and efficiencies...Senior
- ...Senior Regulatory Affairs Specialist At Boston Scientific, we'll give you the opportunity to harness all... ...for Regulatory Affairs support of submissions and ongoing regulatory compliance for... ...through partnership with our global R&D, manufacturing, clinical, and quality...SeniorWork at officeLocal area3 days per week
$94k - $150k
...Senior Regulatory Affairs Specialist, Ultrasound The Senior Regulatory Affairs Specialist for Ultrasound... ...coordinating and preparing regulatory submission documents for agencies such as the... ...Device Licenses—for various global markets. Support cross-functional...SeniorFull timeWork at officeLocal areaWork visaRelocation package3 days per week$110k - $160k
...part of our great team! The Senior Regulatory Affairs Specialist will lead and execute regulatory... ...obstructive sleep apnea. This role supports global regulatory activities with primary... ...and submit high-quality regulatory submissions in the U.S. for PMA, IDE,...SeniorWork experience placementLocal areaFlexible hours$76.1k - $126.9k
...Join Stryker Group as a Regulatory Affairs Specialist in Bloomington, MN. This role focuses on supporting... ...through documentation and global compliance efforts. The ideal candidate... ...regulatory data, supporting audits and submissions, and ensuring compliance across markets...$110.18k - $120k
...Heraeus Medevio in Fridley, MN is seeking a Regulatory Affairs Specialist responsible for initiating global regulatory strategies for medical devices. This role involves preparing and reviewing FDA 510(k) submissions and ensuring compliance with regulations. The ideal...Remote work- Abbott Laboratories in Plymouth, MN is looking for a Regulatory Affairs Specialist I to handle regulatory submissions and ensure compliance for product market entry. You will work in a global healthcare leader dedicated to advancing technology for heart disease treatment...
$110.18k - $120k
...Heraeus Holding GmbH in Fridley, Minnesota is looking for a Regulatory Affairs Specialist to initiate global regulatory strategies for medical devices. This position involves preparing FDA 510(k) submissions and ensuring compliance with international regulations. The ideal...- ...Elucent Medical, Inc. is hiring a Principal Regulatory Affairs Specialist in Eden Prairie, MN. This role requires advanced knowledge of U.S. FDA regulations to oversee regulatory strategies, submissions, and compliance for medical devices. The position emphasizes hands...Senior
$113.03k - $165.77k
...job is to strategically plan, execute and provide oversight to regulatory activities necessary to obtain and maintain regulatory... ...Develops US and International regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing....SeniorImmediate start- Stratasys Ltd is seeking a Sr. Import/Export Analyst to ensure compliance with import/export regulations and optimize international shipping processes. The role involves working closely with logistics and finance to facilitate efficient cross-border trade. Qualified candidates...Senior
$78k - $156k
...serves as the Structural Heart (SH) Regulatory Affairs (RA) Global Regulatory Compliance process lead;... ...resolution. Performs regulatory product submissions for projects covering multiple... ...mentoring and leadership to Regulatory Specialist I and II team members. Required Qualifications...SeniorFor contractorsWork experience placementWorldwide$75.3k - $150.7k
...lives. The Opportunity Abbott is seeking a passionate, experienced Senior Regulatory Affairs Specialist to join our team on-site in Plymouth, MN. In this role, you will lead the preparation and submission for regulatory approvals and identify and resolve problems. You...SeniorFor contractorsWorldwide- ...Stereotaxis, Inc. is seeking a Regulatory Affairs Specialist II to provide hands-on support for new product marketing approvals and renewals. This... ...role requires evaluating regulatory pathways, preparing submissions for authorities like the FDA, and ensuring compliance...Work at office
- ...Integer Holdings Corporation is looking for a Regulatory Affairs professional in Plymouth, Minnesota. You will provide team support to ensure compliance with regulations, manage regulatory submissions, and engage in quality system audits. Ideal candidates possess a Bachelor...
$73.6k - $110.4k
...Medtronic is seeking a Regulatory Affairs Specialist to develop strategies for product registration worldwide, focusing on adherence to FDA and... ...with Class III medical devices and be skilled in regulatory submissions. The role is onsite four days a week and offers a...Worldwide- ...Licensing Analyst Optum is a global organization that delivers care, aided by technology... ...compliance with federal and state regulatory requirements, which shall include, home... ...and Product leadership to ensure timely submissions, proactive risk identification, and sustained...SeniorHourly payMinimum wageFull timeWork experience placementLocal areaRemote work
- ...Research & Diagnostic Systems, Inc. is seeking an Advanced Regulatory Affairs Specialist to manage regulatory activities and ensure compliance... ...Minneapolis, MN. The role involves preparing regulatory submissions and providing strategic regulatory guidance during product...
- ...Incredible opportunity to shape global regulatory strategy and deliver breakthrough science while... ...with cross-functional teams and senior leadership to drive clarity, alignment,... ...effectiveness, process efficiency, and submission readiness. • Prepare and deliver strategic...SeniorWork at officeRemote workWork from homeWorldwide
$102.1k - $194k
...week. Responsibilities Represent the Regulatory Affairs function on cross‑functional teams for... ...EU regulatory strategies and prepare submissions for Class II medical devices. Create innovative... ...product and project information to global regulatory teams and communicate...Work at officeLocal areaOverseas3 days per week$142.8k - $196.35k
...Principal Regulatory Affairs Specialist (Remote - United States) page is loaded## Principal Regulatory Affairs... ...with ownership of product‐line regulatory submissions and registrations for the Dental Solutions business across global markets* Driving regulatory strategy and...H1bRemote workRelocation packageFlexible hours- ...Principal Regulatory Affairs Specialist At Boston Scientific, we'll give you the opportunity to harness... ...and implementing regulatory submissions to the U.S. Food and Drug Administration... ...product and project information to global regulatory teams and communicate international...Work at officeLocal areaWorldwide3 days per week
- ...Parexel is seeking Project Leaders and Senior Project Leaders for their Biotech Division in Saint Paul, Minnesota. The roles require leadership in overseeing global clinical trials within a matrixed environment. Candidates should have at least an undergraduate degree in...Senior
$133.7k - $200.6k
...responsible for leading a complex organization in Saint Paul, MN, focusing on improvement analyses and problem-solving within the Global Supply Chain. The ideal candidate has at least 8 years of relevant experience and demonstrates strong leadership skills to drive team...Senior$120k - $180k
...Principal Regulatory Affairs Specialist At Medtronic, you can begin a life-long career of exploration... ...with experience developing global regulatory strategies and leading worldwide... ...They will manage strategy meetings and submissions to the FDA and EMA (under the EU MDR...H1bWork at officeLocal areaWorldwideRelocationFlexible hours$120k - $180k
...individual will also perform other regulatory duties. As one of three... ...passionate Principal Regulatory Affairs Specialist with experience developing global regulatory strategies and... ...will manage strategy meetings and submissions to the FDA and EMA (under the EU...H1bWork at officeLocal areaWorldwideRelocationFlexible hours- ...Thomson Reuters is seeking a Senior Marketer for their Global Print Marketing team. This role focuses on developing and executing integrated marketing campaigns to drive e-store revenue growth, working collaboratively across various global markets. The ideal candidate...Senior
$89k - $110k
...A global logistics provider is seeking a Field Sales Executive II in Eagan, Minnesota. This role involves establishing relationships with new customers, driving sales, and meeting targets. Candidates should have extensive logistics knowledge and sales experience, preferably...Senior
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