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Regulatory affairs manager Jobs in Pittsburgh, PA

Last updated: 1 day ago
Senior Specialist Global Regulatory Affairs Operations

Senior Specialist Global Regulatory Affairs Operations

OlympusCenter Valley, PA, US-0610
$83,187.00–$112,302.00 yearly
The Senior Specialist, Regulatory Affairs Operations – Regulatory Intelligence is responsible for providing regulatory intelligence support globally, in relation to the Olympus portfolio and the re...Show moreLast updated: 30+ days ago
Public Affairs Coordinator

Public Affairs Coordinator

Dollar BankPittsburgh, PA
Full-time
Dollar Bank is hiring for a Public Affairs Coordinator.In this role, you will assist in the day-to-day operation of the Bank's Public Affairs department and collaborate with staff at all levels of ...Show moreLast updated: 8 days ago
  • Promoted
Accounting Expert - FDIC Regulatory Reporting Project Management

Accounting Expert - FDIC Regulatory Reporting Project Management

PNC Financial Services Group, Inc.Pittsburgh, PA, US
Full-time +1
At PNC, our people are our greatest differentiator and competitive advantage in the markets we serve.We are all united in delivering the best experience for our customers.We work together each day ...Show moreLast updated: 10 days ago
Manager Regulatory Readiness

Manager Regulatory Readiness

Highmark HealthPittsburgh PA
Full-time
Create a culture of continuous regulatory readiness through continual proactive risk assessment and mitigation efforts.Manage, oversee and coordinate all activities related to maintaining an ongoin...Show moreLast updated: 30+ days ago
Sr. Business Analyst- Regulatory Reporting

Sr. Business Analyst- Regulatory Reporting

PNC Bank NAPittsburgh , PA
Full-time
Base Salary : Commensurate with skills and experience.PNC offers employees a comprehensive range of benefits to help meet your needs now and in the future. Depending on your eligibility, options for ...Show moreLast updated: 30+ days ago
  • Promoted
REGULATORY & QUALITY MANAGER

REGULATORY & QUALITY MANAGER

Thomas Jefferson University Hospitals, Inc.PA, United States
Full-time
Quality Safety Program Manager.Under the direction of the Directors, Regulatory and Quality, the Regulatory & Quality Manager is responsible for general regulatory functions that include but are no...Show moreLast updated: 4 days ago
  • Promoted
Public Affairs Coordinator

Public Affairs Coordinator

Dollar Bank, FSBPittsburgh, PA, United States
Full-time
Dollar Bank is hiring for a Public Affairs Coordinator.In this role, you will assist in the day-to-day operation of the Bank's Public Affairs department and collaborate with staff at all levels of ...Show moreLast updated: 8 days ago
Insourced Solutions for Tax - Controversy & Regulatory Senior Manager

Insourced Solutions for Tax - Controversy & Regulatory Senior Manager

PwC US Tax LLPPittsburgh,PA
Full-time
SummaryA career within United States National Tax services, will provide you with the opportunity to help our clients gain valuable insight into emerging tax issues and trends, as well helping them...Show moreLast updated: 30+ days ago
Medical Affairs Lead, CT Devices

Medical Affairs Lead, CT Devices

BayerIndianola, Pennsylvania, US
$177,584.00–$266,376.00 yearly
At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility.We’re doing ...Show moreLast updated: 30+ days ago
Senior Specialist Global Regulatory Affairs Operations

Senior Specialist Global Regulatory Affairs Operations

Olympus Corporation of the AmericasCenter Valley, PA, US
$83,187.00–$112,302.00 yearly
For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling.Every day, we live by our philosophy, True to Life, by advancing medical technologies and ...Show moreLast updated: 30+ days ago
Regulatory Reporting Senior Manager

Regulatory Reporting Senior Manager

Huntington National BankPittsburgh, PA
Full-time
At the direction of the Head of Regulatory Reporting, our Regulatory Reporting Senior Manager will have primary responsibility for managing short term and long term, complex regulatory reporting re...Show moreLast updated: 30+ days ago
Manager of Public Affairs

Manager of Public Affairs

Allegheny CountyPittsburgh, Pensilvania, US
$90,000.00–$110,000.00 yearly
Under the supervision of the Director of Team Transformation, the Manager of Public Affairs leads Allegheny County Treasurer’s Office media relations and public affairs initiatives and activities.R...Show moreLast updated: 30+ days ago
Proxy & Regulatory Coord

Proxy & Regulatory Coord

Federated HermesPittsburgh, US
Associate degree OR High School diploma (or equivalent) with related proxy and regulatory experience required.Experience in proxy and regulatory services processing and / or the mutual fund industry ...Show moreLast updated: 30+ days ago
Medical Director (Medical Affairs)

Medical Director (Medical Affairs)

CVS HealthPennsylvania, Work At Home, US
Remote
Full-time
Bring your heart to CVS Health.Every one of us at CVS Health shares a single, clear purpose : Bringing our heart to every moment of your health. This purpose guides our commitment to deliver enhanced...Show moreLast updated: 30+ days ago
Regulatory Affairs Assistant

Regulatory Affairs Assistant

Axelon Services CorporationPittsburgh, PA, United States
Full-time
Job Title : Regulatory Affairs Assistant.Responsible for assisting with ensuring compliance with US OSHA and Canadian Workplace Hazardous Materials Information System (WHMIS).This includes gatherin...Show moreLast updated: 3 days ago
Assistant Vice President, Research Regulatory Affairs - OVPR

Assistant Vice President, Research Regulatory Affairs - OVPR

Carnegie Mellon UniversityPittsburgh, PA
Full-time
The Office of the Vice President for Research (OVPR) at Carnegie Mellon University (CMU) is seeking a highly motivated, resourceful, and trustworthy individual to support the senior leadership team...Show moreLast updated: 30+ days ago
  • Promoted
Business Analytics Lead - FDIC Regulatory Reporting

Business Analytics Lead - FDIC Regulatory Reporting

PNC Financial Services GroupPittsburgh, PA, US
Full-time +1
At PNC, our people are our greatest differentiator and competitive advantage in the markets we serve.We are all united in delivering the best experience for our customers.We work together each day ...Show moreLast updated: 1 day ago
Senior Specialist Global Regulatory Affairs Operations

Senior Specialist Global Regulatory Affairs Operations

OlympusCenter Valley, PA, US-0610
30+ days ago
Salary
$83,187.00–$112,302.00 yearly
Job description

Job Description

The Senior Specialist, Regulatory Affairs Operations – Regulatory Intelligence is responsible for providing regulatory intelligence support globally, in relation to the Olympus portfolio and the regulatory landscape (e.g., international and domestic standards & regulations). The Senior Specialist will act as a point of contact in monitoring standards and the regulatory landscape, disseminating regulatory intelligence impact assessments to cross functional stakeholders, and facilitating the activities described by a global regulatory intelligence process.

Job Duties

The Senior Specialist, Regulatory Affairs Operations – Regulatory Intelligence will perform the following :

  • Perform regular monitoring of the regulatory environment, to identify potential Regulatory Intelligence which may impact Olympus’ product portfolio.
  • Aggregate identified Regulatory Intelligence and perform quality checks to confirm that information is accurate.
  • Provide cross functional stakeholders (internal and external to Regulatory Affairs) with impact assessment information to partner with teams to support implementation of regulatory intelligence and regulatory compliance of Olympus’ portfolio and operations.
  • Monitor the implementation status of new regulatory requirements based on Regulatory Intelligence.
  • Drive quality mindset to reinforce the corporate brand and become a trusted, collaborative and preferred business partner across Olympus.
  • Provide guidance to cross-functional stakeholders on the regulatory intelligence global process.
  • Monitor and maintain global process tracking information to inform KPIs and ensure efficiency and quality of tasks.

Job Qualifications

Required :

  • Bachelor’s degree in Engineering, Non-Medical or Science (or similar) is required. Master’s degree preferred.
  • Experience in medical device Regulatory Affairs, Quality Assurance, or Research & Development (minimum 5 years), ideally in a matrix organization.
  • Experience supporting significant parts of the end-to-end product lifecycle management activities.
  • Has a broad understanding of the global medical device regulatory landscape, regulatory submissions (e.g., 510(k), CE Mark etc), and international standards utilized to demonstrate conformance with regulatory requirements.
  • Experience operating within regulated environments, QMS processes and systems.
  • Experience working globally with understanding of global process flows and teaming.
  • Strong IT skills – experience utilizing a relevant regulatory system (desirable, e.g., RIM / PLM), QMS systems (essential) and basic Office applications (essential), including MS Office (Word, Excel, PowerPoint, Outlook, Teams)
  • Travel may be required 10-20% of the time (both domestic and international). Global regulatory intelligence activities may require availability outside of normal work hours.
  • Preferred :

  • Qualified candidates will ideally have regulatory project management support experience, in particular covering regulatory intelligence, project management, submissions, and publications.
  • Leadership and strong interpersonal skills to develop and manage good working relationships within Regulatory Affairs and with other internal departments (R&D, Manufacturing, Supply Chain, Quality etc)
  • Strong written, verbal, and presentation communication skills.
  • Why join Olympus? We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture. Equitable Offerings you can count on :

    Competitive salaries, annual bonus and 401(k)

  • with company match
  • Comprehensive medical, dental, vision coverage effective on start date

    24 / 7 Employee Assistance Program

    Free live and on-demand Wellbeing Programs

    Generous Paid Vacation and Sick Time

    Paid Parental Leave and Adoption Assistance

    12 Paid Holidays

    On-Site Child Daycare, Café, Fitness Center

    Connected Culture you can embrace :

    Work-life integrated culture that supports an employee centric mindset

    Offers onsite, hybrid and field work environments

    Paid volunteering and charitable donation / match programs

    Employee Resource Groups

    Dedicated Training Resources and Learning & Development Programs

    Paid Educational Assistance

  • US Only
  • Center Valley, PA and Westborough, MA Are you ready to be a part of our team? . The anticipated base pay range for this full-time position working at this location is $83,187.00 - $112,302.00  / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including : level of experience, working location, and relevant education and certifications. At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit . You Belong at Olympus We value a workforce that reflects a wide range of perspectives, backgrounds, and experiences. We foster an environment where all employees feel valued, respected, and supported. And we provide employees with equal access to opportunities for growth and development. Let’s realize your potential, together. It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and / or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and / or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law. Posting Notes : || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA / RA)