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As the Director of Regulatory Affairs andQuality Assurance (RA/QA), this position is responsible for ensuring global leadership in RxFunction byinfluencing the creation of,and ensuring compliance with, the global regulatory requirements for the company's emerging medical device initiatives. This position willinteract with the FDA, Notified Bodies, and other regulatory authorities asneededtodeveloptheregulatory strategies andtomanageallaspects of their execution regarding RxFunction products.

RxFunction

Director of Regulatory Affairs and Quality Assurance (RA/QA)

Brightmove

In this pivotal role, you will work cross-functionally with internal teams and external stakeholders to ensure regulatory compliance, provide consultation on regulatory aspects during the development phase, ensure all activities are planned and executed for a successful submission. We’ve already established a successful track record of launching first-to-file and first-to-market generic pharmaceutical products that have helped to make prescription products more affordable for patients and reduce costs for the healthcare system.

Padagis

Associate Director/Director for Regulatory Affairs

Because our community is a significant part of our mission and the development of our students and listeners, all employees serve as ministers of the gospel of Jesus Christ by actively partnering with the University to disciple students as they grow intellectually and spiritually, and with Northwestern Media to lead people to Christ and nurture believers to maturity in their faith. Key Responsibilities: Provide strategic leadership for the university's assessment and institutional effectiveness efforts, ensuring alignment with institutional strategic planning and priorities while fostering a culture of evidence-based decision-making and continuous improvement across academic and administrative units.

YEAR

University of Northwestern St. Paul

Director of Assessment, Academic Affairs

Because our community is a significant part of our mission and the development of our students and listeners, all employees serve as ministers of the gospel of Jesus Christ by actively partnering with the University to disciple students as they grow intellectually and spiritually, and with Northwestern Media to lead people to Christ and nurture believers to maturity in their faith. • Provide strategic leadership for the university’s assessment and institutional effectiveness efforts, ensuring alignment with institutional strategic planning and priorities while fostering a culture of evidence-based decision-making and continuous improvement across academic and administrative units.

St. Paul

In close partnership with internal stakeholders, this role cultivates relationships and engages with federal legislators, congressional staff, administration officials, and regulators to advance Regeneron's patient-centered, science-driven mission. Lead engagement with federal legislators, administration officials, and regulators to proactively shape policy outcomes, serving as a key advocate to House Democratic members and staff, including the Energy & Commerce Committee.

At Regeneron, we believe in the power of original thinking. Our company is built on breakthrough ideas; which is why we foster a spirit of openness, and strive to inspire from within. We are collaborative by design and driven by curiosity. Each one of us plays an active role in transforming people’s lives through our work. Regeneron’s people make us who we are, and we are truly more than a company &ndash; we’re a community. Simply put, we’re a tight-knit group working together to change the world.

Regeneron Pharmaceuticals

Senior Director, Federal Government Affairs

ea_via_bold

Provides leadership, oversight and direction of pharmacy staff development and educational activities; pharmacy student experiential training programs including internships and advanced pharmacy practice experiences; post-graduate residency training programs; and new employee orientation and staff competency training. Completion of an accredited PGY2 pharmacy residency and a minimum of 1 year applicable pharmacy experience; or completion of an accredited PGY1 pharmacy residency and a minimum of 3 years applicable pharmacy experience; or a minimum of 5 years applicable pharmacy experience.

Mayo Clinic

Director - Pharmacy Education/Academic Affairs

As a Regulatory Affairs & Product Stewardship Specialist within the Filtration & Separation business, you will support regulatory and product stewardship activities for a diverse portfolio of filtration, purification, bioprocessing, and life sciences products. This position plays a critical role in helping ensure products remain compliant, safe, and sustainable throughout their lifecycle while supporting business growth, innovation, and customer success.

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

Lancesoft

Regulatory Affairs Specialist

HaleyMarketing

This role will partner closely with Geography Regulatory Affairs to support international submissions, government queries, registration documentation, product approval and clearance activities, product demand and release planning, and post-market regulatory compliance to help ensure continued product availability worldwide. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

Medtronic Plc

Sr Regulatory Affairs Spec

If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

Principal Regulatory Affairs

The Regulatory Affairs Specialist assists in the development of strategies for worldwide product registration with global regulatory agencies to introduce Diagnostic products, Programmers and Programming Software and accessories for Pacemakers and Defibrillators, Patient Monitors, and Software as a Medical Device to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

Medtronic

Sr. Principal Regulatory Affairs Strategy Specialist

Serves as the U.S. FDA Regulatory Affairs strategic partner to the Global Heads of Regulatory Strategy (Therapeutic Dermatology, DS and IA), providing strategic leadership on FDA engagement, regulatory submissions, and Health Authority interactions to ensure alignment of U.S. regulatory strategy with global development objectives and successful product development and lifecycle management. Represents Global Regulatory Affairs (GRA) on core development and cross-functional project teams, collaborating with regional and global leaders to ensure a unified regulatory approach that supports FDA interactions and global commercial strategy.

Galderma

Senior Director, Regulatory Strategy & Policy

Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases. Serve as a thought leader on regulatory affairs, defining regulatory strategy and plan to maximize regulatory success in our next generation anti-myostatin therapy and US regulatory representative for new indication for an approved product.

Scholar Rock

Associate Director, Regulatory Strategy

Knowledge/Skills/Abilities: Knowledge of neuroscience and/or biomedical science Excellent verbal and written communication Ability to think creatively, dynamically, and foster a culture of commitment to thoughtful science to help patients in need Demonstrated leadership experience, including excellent strategic, analytical, planning, and communication skills in a dynamic, fast-paced environment Leadership style that demonstrates professionalism, encourages accountability, and establishes an environment of mutual respect Maturity, confidence and credibility to advise and influence senior management Excellent organizational and project management skills with a high degree of attention to detail High degree of personal integrity. What Youll Bring: 15+ years direct clinical and/or medical affairs experience in medical devices including experience with Active Implantable Medical Devices A minimum of a Masters degree in science/biomedical/health related field; PhD preferred Experience with neurostimulation industry preferred Active implantable experience in neuromodulation field preferred Demonstrated success in working with FDA and/or other regulatory and governmental agencies Demonstrated success in developing clinical evidence strategies, and designing and conducting clinical trials in support of medical device and/or pharmaceuticals.

Saluda Medical Pty Ltd

Head of Clinical and Medical Affairs

Located at the heart of one of the nations most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations. Serve as the primary communications advisor to the Dean and senior leadership team, including providing counsel on key initiatives, institutional priorities, public positioning and issues/crisis management; prepare talking points, presentations or other materials to support leaders; provide media coaching; among other support.

The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research.&nbsp; Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.
Our&nbsp;institution is dedicated to changing lives through research, education, and outreach. The Office of Information Technology (OIT) - the University&rsquo;s central IT department - works to support and advance this mission and to support overall academic advancement. Our dedicated IT professionals connect students, faculty, and staff with innovative services to meet their teaching, learning, research, and administrative needs. The Office of Information Technology offers an environment of trust, collaboration, and mission-focused work. Join us and support innovation and engagement through technology!

University of Minnesota

Director of Communications and Marketing

Oversee claim submission and claim management processes, including ensuring claims are documented, submitted, tracked, escalated, and managed through resolution in partnership with Safety Coordinators, Human Resources, Legal, management, insurance carriers, and third-party administrators. Management of the customs compliance functional area, which is responsible for import and export transactions, including entry accuracy, valuation, classification, country of origin, documentation completeness, and filing timeliness.

Director Of Compliance

This individual will serve as the company's primary subject matter expert on coding, coverage, and payment policy — working cross-functionally with Sales, Commercial, Clinical, Regulatory, and Finance to ensure that providers and patients can access Sanuwave technologies with minimal reimbursement barriers. Develop and execute reimbursement strategies for new and existing medical device product lines, including coding (CPT, ICD-10, HCPCS), coverage, and payment pathway planning.

SANUWAVE, Inc

Director of Medical Device Reimbursement and Market Access

Proliant

JOB SUMMARY: The Director of Risk Management & Compliance is responsible for leading the organization's governance framework, enterprise risk management program, compliance activities, contract administration, legal affairs coordination, and security functions. Other duties may be assigned: Steward our mission (to enrich lives by providing differentiated packaging automation and services) and values (unwavering integrity, servant's heart, ownership spirit and continuous innovation and improvement).

Director Of Regulatory Affairs Jobs in Minnesota

Director of Regulatory Affairs and Quality Assurance (RA/QA) RxFunction

Associate Director/Director for Regulatory Affairs Padagis

Director of Assessment, Academic Affairs University of Northwestern St. Paul

Director of Assessment, Academic Affairs St. Paul

Senior Director, Federal Government Affairs Regeneron Pharmaceuticals

Director - Pharmacy Education/Academic Affairs Mayo Clinic

Regulatory Affairs Specialist Lancesoft

Sr Regulatory Affairs Spec Medtronic Plc

Principal Regulatory Affairs Medtronic Plc

Regulatory Affairs Specialist Medtronic Plc

Sr. Principal Regulatory Affairs Strategy Specialist Medtronic

Sr. Principal Regulatory Affairs Strategy Specialist Medtronic Plc

Regulatory Affairs Specialist Medtronic

Senior Director, Regulatory Strategy & Policy Galderma

Associate Director, Regulatory Strategy Scholar Rock

Head of Clinical and Medical Affairs Saluda Medical Pty Ltd

Director of Communications and Marketing University of Minnesota

Director Of Compliance QBP

Director of Medical Device Reimbursement and Market Access SANUWAVE, Inc

Director of Risk Management and Compliance Douglas Machine Inc

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