Director of Quality and Regulatory Affairs

Denver, CO, US


Apply Apply with LinkedIn Back to Results

Type: Perm Contingent

Company: Shurig Solutions, Inc.

Salary: 220k/year - 250k/year

Reference ID: 6kP2hT

Date Posted: 04/16/2026

Shortcut: http://jobs.mrinetwork.com/lfa7JZ


As Director of Regulatory Affairs – Compliance Systems and Labeling, you’ll direct regulatory and labeling activities and collaborate with senior teams to define strategy and compliance programs. You’ll play an integral part in launching new products, supporting established lines, and driving initiatives that ensure success across the entire lifecycle. If you thrive on strategic influence and want to champion quality and compliance at a global scale, we’d love to connect with you.


DUTIES AND RESPONSIBILITIES

• Provides strategic direction and operational leadership for regulatory affairs in a business area or region.

• Provides strategic direction and operational leadership for global labeling.

• Develops and communicates effective regulatory strategies to meet established business goals.

• Provides intentional influence to ensure a robust, day-to-day ‘culture of quality and compliance’ exists in the business area or region.

• Acts as an internal champion for quality and regulatory initiatives aimed at improving business systems and compliance.

• Works closely with other senior-level colleagues within and outside of the company to resolve highly complex and sensitive issues.

• Fosters an ongoing proactive relationship with internal R&D, Clinical, Scientific, Quality, Legal, Manufacturing, and Marketing colleagues.

• Influences internal customers as necessary to ensure a successful strategy implementation.

• Directs the professional growth of professional staff by providing individualized guidance, training, and supervision.

• Participates in Management Teams for business areas.

• Develops Regulatory presentation for Regulatory section of Management Review and participates in the meeting.

• Oversees the development of 510(k)s, IDEs, PMAs, CE Technical Files, CE Design Dossiers, NDA’s and ANDA’s and other international regulatory submissions.

• Acts as primary interface with applicable regulatory bodies, presenting strategies and technology communications effectively.

• Acts as Regulatory PRRC and performs required PRRC activities.

• Ensures that all regulatory activities are conducted with the highest integrity in an ethical, legal, and compliant manner.

• Provides support for the development of new products, from design inputs including clinical and regulatory specifications through comprehensive design validation

support

• Determines the adequacy of new products/processes prior to and following commercial distribution.

• Works closely with Quality Assurance to ensure that the Quality Management System is maintained for effectiveness in accordance with applicable standards and regulations.

• Identifies areas of regulatory or compliance risk and develops mitigating strategies.

• Directs compliance programs such as the Standard Assessment program, UDI compliance, and State License program, as well as Regulatory Operations.

• Identifies areas of regulatory or compliance risk and develops mitigating strategies and works to implement solutions cross-functionally.


 MINIMUM QUALIFICATION REQUIREMENTS

Education

• Four-year college degree is required, and an advanced degree in the physical sciences is considered a plus.

• Professional education in Regulatory Sciences desired, with regulatory certification a plus.


Experience

• Minimum of 10 years of regulatory experience with increasing responsibility in the medical device or pharmaceutical industry.

• Experience with both sterile disposables and electromechanical medical devices with embedded software preferred.

• Knowledge of the software in medical device regulations is preferred.

• Experience with pharmaceutical submissions (NDA/ANDA in eCTD format) or medical device submissions (510(k), PMA, CE mark, etc.).

• Minimum 5 years of managerial experience with multiple direct reports.

• A demonstrated track record of representing unique technologies to regulatory authorities and gaining timely approvals is critical. Work with drug/device combination products is desired.

• Demonstrated effective leadership and strategic planning skills in environments where regulatory guidelines have not been developed and where creativity can

impact approval timelines.

• Experience working closely with clinical experts in all stages of clinical trials.

• Experience in regulatory compliance requirements desired (Health Hazard Evaluations, Removals and Corrections, Adverse Event Reporting, Promotional

Material review, etc.)

• Direct experience in and knowledge of business and management principles involved in tactical execution, strategic planning, resource allocation, human resources modeling, leadership techniques, production methods, and coordination of people and resources.

• Experience working in Quality or leading a Quality team is preferred.


Skills

• Ability to solve practical problems and interpret and communicate complex regulatory requirements in a manner that allows maximum product flexibility without compromising regulatory compliance.

• Demonstrated ability to select, manage, motivate, lead, influence, and develop regulatory skills in coworkers of varying levels of experience.

• Capacity to define and communicate regulatory challenges and provide guidance to top management by developing and implementing positive and proactive solutions.

• Excellent written and oral communication skills and a proven ability to communicate effectively. Proven ability to read and interpret documents of significant complexity, including external standards, design inputs, verification/validation protocols, and clinical studies.

• Demonstrated ability to interact productively and to effectively influence peers, external colleagues, and senior management.

• Willingness to take ownership and accept responsibility for actions and decisions.

• Regulatory expertise complemented by strong operational, logistical, communication, and business skills.

• Knowledge of current US and non-US regulatory requirements, such as the EU and Canada, and trends affecting medical devices and pharmaceuticals.

• Ability to help the management team balance regulatory requirements with business requirements and identify solutions to meet both sets of needs.

• Strong interpersonal and conflict management skills, maturity, good judgment, and capable of communicating with a diverse range of individuals.

• Must be detail-oriented, well-organized, and able to work both independently and in teams.


  • Credit Administrator

     Sacramento, CA
     Sales Consultants of Sacramento

    Excellent opportunity for a Credit Administrator with one of the most successful, well-capitalized financial institutions in the country. The Credit Administrator is responsible for the administration and management of the Commercial loan process inclu...

    Date Posted: 02/23/2026 Recommended

  • Sanitation Supervisor

     Medford, WI, United States
     Manta Resources, Inc.

    Sanitation Supervisor who will be responsible for developing, implementing, and maintaining strategic sanitation programs, policies, plans, and processes to ensure that sanitary performance meets company standards as well as regulatory compliance. This...

    Date Posted: 04/23/2025 Recommended

  • Controls Engineer

     Saint Louis, MO, 63143
     Management Recruiters of Tallahassee

    Controls Design Engineer Position Summary: We are seeking an experienced Controls Design Engineer to join our team. The ideal candidate will design electrical, hydraulic, and pneumatic control systems, utilizing Beckhoff computers to manage servo motor...

    Date Posted: 10/09/2025 Recommended

  • Chief Revenue Cycle Officer

     Midwest
     The HealthCare Initiative

    I have been engaged in leading a search for a Chief Revenue Cycle Officer for a large, integrated not for profit health system in the Midwest. This executive will report to the CFO of the system, who is described as someone who you can easily connect a...

    Date Posted: 03/04/2026 Recommended

  • 2466m - Manager, Electric Distribution System Planning

     Boston, Massachusetts, United States
     Management Recruiters of Bonita Springs

    The successful manager will ensure the optimal performance and utilization of system assets through the management of the System Planning area for the Company’s Massachusetts service area while managing the assessment of system adequacy and reliability...

    Date Posted: 03/26/2026 Recommended

  • Human Resources Manager

     Northwest New Jersey
     Highland Consulting Group, Inc.

    We are seeking a well-rounded and experienced Human Resources professional to join a collaborative, service-focused and highly regulated organization. This role will serve as a trusted partner to the Human Resources Director, operating with a high degr...

    Date Posted: 02/26/2026 Recommended

  • Hybrid Director of Government Payment Programs

     Texas, United States
     The HealthCare Initiative

    This is one of the largest faith-based, non-profit healthcare systems in Texas! I have placed with this system several times and can tell you about their financial viability, their culture, and their constant aim towards excellent patient care. The Dir...

    Date Posted: 03/19/2026 Recommended

  • Certified Prosthetist/Orthotist (CPO) - Miami, FL

     Miami, Florida, United States
     The Newell Group

    Are you an experienced Certified Prosthetist-Orthotist (CPO) ready to step into a role where your clinical excellence and strategic vision will drive growth and enhance patient care? Our client, a respected orthotic and prosthetic practice serving dive...

    Date Posted: 03/19/2026 Recommended

  • Chief Financial Officer

     Ohio, United States
     The HealthCare Initiative

    Chief Financial Officer Independent Community Health System | Midwest This is a rare opportunity to step into a CFO role with true enterprise influence -where strategy, operations, and impact intersect. We are conducting a confidential search for a Chi...

    Date Posted: 04/06/2026 Recommended

  • President and Chief Executive Officer

     Denver, CO, US
     Highland Consulting Group, Inc.

    President and Chief Executive Officer We are conducting a retained search for a President and Chief Executive Officer for a $400 million WV community bank. This is a tremendous opportunity for someone to build upon the bank’s successes to date and buil...

    Date Posted: 03/03/2026 Recommended

  • 2477m - Vice President, Electric Utilities (Remote)

     United States
     Management Recruiters of Bonita Springs

    The Vice President, Electric Utilities will report to the Sr. Vice President, Utilities and will lead a strategic, Enterprisewide Energy team charged with integrating transmission solutions to enable large-scale data center developments across the Amer...

    Date Posted: 03/20/2026 Recommended

  • Credit Administrator

     Walnut Creek, CA
     Sales Consultants of Sacramento

    Excellent opportunity for a Sr. Credit Administrator with one of the most successful, well-capitalized financial institutions in the country. The Sr. Credit Administrator reports directly to the Chief Credit Officer and is responsible for the administr...

    Date Posted: 02/23/2026 Recommended

  • Director of Emergency Services

     Missouri, United States
     The HealthCare Initiative

    THE HEALTHCARE INITIATIVE Where Talent Meets Opportunity Director of Emergency Department Community Hospital | Midwest A community-based medical center in the Midwest is seeking a Director of Emergency Department to lead an 11-bed ED with approximately...

    Date Posted: 03/26/2026 Recommended

  • Director of Quality and Risk Management

     Modesto, California, United States
     Siter-Neubauer & Associates

    Director of Quality and Risk Management Modesto, CA ABOUT THE COMPANY: This acute care hospital is a respected healthcare provider serving the Modesto, California community. The organization is dedicated to delivering safe, high-quality, patient-center...

    Date Posted: 01/19/2026 Recommended

  • Director of Supply Chain

     Ohio, United States
     The HealthCare Initiative

    Director of Supply Chain Ohio, Ohio | Permanent Director of Supply Chain Where operational discipline meets financial strategy. Hospitals don’t run without great clinicians. They don’t stay strong without great supply chain leadership. We are seeking a...

    Date Posted: 02/23/2026 Recommended

  • Project Manager

    Aiken, South Carolina, United States
     Management Recruiters of Lowcountry

    MR Lowcountry, LLC. Nebo, NC 28761 Telephone: 843-628-5021 tom@mrlowcountry.com The company works across industries and value chains to accelerate the transition to BioAlternatives – better performing and more sustainable versions of complex molecules ...

    Date Posted: 03/02/2026 Recommended

  • Global VP of IT Applications & Architecture (US, UK, EU, So. Africa)

     United States
     The Trevi Group

    * * * This position has been filled. * * * Position Title: VP of IT Applications & Architecture - Location: Remote office in the UK, EU, or South Africa. Or Hybrid from CT, TX, OK, MS in USA. - Compensation: Lucrative base and bonus, long term incentiv...

    Date Posted: 04/04/2025 Recommended

  • Project Coordinator

     New York, New York, United States, 10036
     Northbound Executive Search

    Our client, an international broker-dealer located in Midtown, NY, is looking to add a regulatory Project Coordinator to their Technology Infrastructure team. This person will be responsible for the delivery of several firm-wide initiatives related to ...

    Date Posted: 02/25/2026 Recommended

  • VP, Real Estate

     Dallas/Fort Worth, Texas, United States
     Management Recruiters of Cumming

    The Vice President of Real Estate is responsible for overseeing the organization’s entire real estate portfolio, including leases, site strategy, maintenance, and procurement. This role plays a critical part in supporting current operations while drivi...

    Date Posted: 03/30/2026 Recommended

  • Director of Cardiovascular Services

    Detroit, Michigan, United States
     Siter-Neubauer & Associates

    Director, Cardiovascular Services 📍 Detroit, MI Lead and Elevate Cardiovascular Service Excellence A respected Detroit healthcare system is seeking an accomplished Director of Cardiovascular Services to oversee strategic planning, operations, quality,...

    Date Posted: 01/19/2026 Recommended

  • 2481m - Director, Power Delivery, Data Centers (Remote)

     United States
     Management Recruiters of Bonita Springs

    The Director, Power Delivery will report to the Vice President, Power Delivery and will be responsible for developing and executing on near-term and long-term strategies to help the Development team integrate data center projects. The Director will be ...

    Date Posted: 04/03/2026 Recommended

  • Perioperative Manager

    Denver, CO, US
     The HealthCare Initiative

    THE HEALTHCARE INITIATIVE Where Talent Meets Opportunity Perioperative Manager California A progressive, patient-centered healthcare organization is seeking a seasoned Perioperative Manager to lead surgical services across the full continuum of care. T...

    Date Posted: 04/02/2026 Recommended

  • Quality Assurance Manager

     Itasca, IL, US
     Shurig Solutions, Inc.

    Job Title: Quality Assurance / Quality Manager – Medical Devices Location: Chicago area (Headquarters) Employment Type: Full-Time Position Summary The Quality Manager is responsible for leading the Quality Assurance function and overseeing the Quality ...

    Date Posted: 01/23/2026 Recommended

  • Operations Manager

     Indianapolis, IN, United States
     Manta Resources, Inc.

    The Operations Manager is accountable for the day-to-day operations of plant production departments in an FDA-regulated facility. Performs a wide variety of duties to plan, organize, and coordinate production departments. Oversees several shift manager...

    Date Posted: 04/23/2025 Recommended

  • Marketing Director, Mexico

     Ciudad de Mexico, Mexico
     CP & Krell Group

    COMPANY OVERVIEW Our client is a dynamic and innovative leader in the Beauty industry. Their commitment to excellence and continuous growth has positioned them as a prominent player in the market. As they continue to expand, they are seeking a talented...

    Date Posted: 11/21/2025 Recommended

  • Director of Revenue Cycle Services

     Denver, CO, US
     The HealthCare Initiative

    THE HEALTHCARE INITIATIVE Where Talent Meets Opportunity Director of Revenue Cycle Services Pacific NW Region A progressive, community-focused healthcare organization is seeking a Director of Revenue Cycle Services to lead and optimize the full continu...

    Date Posted: 04/09/2026 Recommended

  • Senior Sales Manager

     Dayton, Ohio, United States
     Snyder Executive Search, Inc.

    Senior Sales Manager Dayton, OH | Full-Time, On-Site | Automotive Manufacturing Up to $110,000 base + 20–40% bonus + car allowance + cell phone credit About the Company We're partnering with a state-of-the-art Tier 1 automotive supplier known for produ...

    Date Posted: 03/13/2026 Recommended

  • Chief Lending Officer

     Corpus Christi, TX
     Sales Consultants of Sacramento

    Excellent opportunity for an EVP/Chief Lending Officer with a very successful regional financial institution. Key executive member. Relocation assistance offered to the right candidate. Oversees all lending areas with the bank. Develops or approves bro...

    Date Posted: 03/11/2026 Recommended

  • SBA Lending Manager

     Remote
    Highland Consulting Group, Inc.

    We’re partnered with a national SBA lender and Community Development Financial Institution (CDFI) with more than 50 years of history providing equity capital, training, and strategic advisory to the communities they serve. With approximately $2B in ass...

    Date Posted: 02/27/2026 Recommended

  • Quality Assurance Engineer

     Ohio, United States
     Management Recruiters of Zionsville (Indianapolis)

    Our client, a leading independent manufacturer of industrial products that are used in a wide range of industries, is actively searching for a Quality Assurance Engineer. Our client is a locally owned, privately held, long-term growth-oriented company....

    Date Posted: 03/26/2026 Recommended