Current jobs related to Senior Specialist in Regulatory Compliance - Littleton, Colorado - Terumo BCT
-
Medication Care Specialist
2 weeks ago
Littleton, Colorado, United States Sunrise Senior Living Full timeJob Title: Medication Care SpecialistSunrise Senior Living is a leading provider of senior care services, and we are seeking a highly skilled Medication Care Specialist to join our team.The Medication Care Specialist is responsible for providing high-quality care and services to our residents by administering medication and treatments in a safe and organized...
-
Senior Medical Safety Quality Specialist
2 weeks ago
Littleton, Colorado, United States Terumo BCT Full timeJob Title: Senior Medical Safety Quality SpecialistAt Terumo Blood and Cell Technologies, we are committed to delivering innovative medical devices and solutions that improve patient outcomes. We are seeking a highly skilled Senior Medical Safety Quality Specialist to join our team.Job Summary:The Senior Medical Safety Quality Specialist will be responsible...
-
Caregiver - Senior Care Specialist
3 weeks ago
Littleton, Colorado, United States Sunrise Senior Living Full timeAbout the RoleSunrise Senior Living is seeking a dedicated and compassionate Caregiver to join our team. As a Caregiver, you will play a vital role in providing exceptional care and services to our residents, ensuring their physical, emotional, and social needs are met.Key ResponsibilitiesBuild meaningful relationships with residents and their families,...
-
HIPAA Compliance Specialist
3 weeks ago
Littleton, Colorado, United States UC Health Full timeJob SummaryWe are seeking a highly skilled HIPAA Specialist to join our team at UCHealth. As a HIPAA Specialist, you will play a critical role in ensuring the organization's compliance with the Health Insurance Portability and Accountability Act (HIPAA) and all other policies, procedures, laws, and regulations concerning protected health information.Key...
-
EHS Specialist
1 week ago
Littleton, Colorado, United States CRH Full timeJob SummaryThe EHS Specialist plays a critical role in ensuring a safe and healthy work environment for all employees. This individual will work closely with management to identify and mitigate hazards, develop and implement safety protocols, and provide training and coaching to employees. The EHS Specialist will be responsible for conducting regular safety...
-
HIPAA Compliance Specialist
3 weeks ago
Littleton, Colorado, United States UC Health Full timeJob SummaryUCHealth is seeking a highly skilled HIPAA Specialist to ensure the organization's compliance with the Health Insurance Portability and Accountability Act (HIPAA) and other relevant laws and regulations. The successful candidate will safeguard patient privacy, maintain accurate medical records, and prioritize release of information requests.Key...
-
Medication Care Specialist
2 weeks ago
Littleton, Colorado, United States Sunrise Senior Living Full timeJob Title: Medication AideSunrise Senior Living is a leading provider of senior care services, and we are seeking a highly skilled Medication Aide to join our team.Job Summary:The Medication Aide is responsible for providing high-quality care and services to our residents by administering medication and treatments in a safe and organized...
-
Caregiver - Senior Care Specialist
2 weeks ago
Littleton, Colorado, United States Sunrise Senior Living Full timeAbout the RoleWe are seeking a compassionate and dedicated Caregiver to join our team at Sunrise Senior Living. As a Caregiver, you will play a vital role in providing high-quality care and services to our residents and their families.ResponsibilitiesBuild meaningful relationships with residents and their families, providing assistance with activities of...
-
Senior Medical Safety Quality Specialist
3 weeks ago
Littleton, Colorado, United States Terumo BCT Full timeJob Title: Senior Medical Safety Quality SpecialistAt Terumo Blood and Cell Technologies, we are committed to advancing healthcare with heart. We are seeking a highly skilled Senior Medical Safety Quality Specialist to join our team.Job Summary:The Senior Medical Safety Quality Specialist will play a key role in ensuring the safety and performance of...
-
Senior Contracts Management Specialist
3 weeks ago
Littleton, Colorado, United States Lockheed Martin Corporation Full timeJob DescriptionLockheed Martin is seeking a highly skilled and experienced Senior Contracts Management Specialist to join our team. As a key member of our contracting team, you will be responsible for managing and negotiating contracts, ensuring compliance with government regulations and company policies.Key Responsibilities:Manage and negotiate contracts...
-
Care Team and Office Manager
1 week ago
Littleton, Colorado, United States Senior Helpers Full timeSenior Helpers of Littleton is seeking a highly skilled and experienced Care Team and Office Manager to join our team. As a key member of our leadership team, you will be responsible for overseeing the recruitment, hiring, training, and supervision of caregivers, as well as managing the day-to-day operations of our office. **Key Responsibilities:**Develop...
-
Littleton, Colorado, United States Terumo BCT Full timeAbout Terumo Blood and Cell TechnologiesWe are proud to be a leading global medical device company dedicated to improving patient outcomes through innovative technologies and solutions. With a strong commitment to quality and safety, we strive to make a positive impact on people's lives.Job SummaryWe are seeking a highly skilled Senior Medical Safety Quality...
-
Senior Performance Engineer
3 weeks ago
Littleton, Colorado, United States DISH Network L.L.C Full timeJob Title: Senior Performance EngineerCompany Summary:DISH Network L.L.C, a leading provider of satellite television service, live-streaming, and on-demand programming, is seeking a highly skilled Senior Performance Engineer to join its Wireless Technology organization. With a strong background in wireless telecommunications and performance engineering, this...
-
Senior Electrical Project Manager
2 weeks ago
Littleton, Colorado, United States Maxson Engineering LLC Full timeJob DescriptionMaxson Engineering LLC is seeking a highly skilled Senior Electrical Project Manager to join our team. As a key member of our project management team, you will be responsible for leading electrical projects from conception to completion, ensuring they are delivered on time, within budget, and to the highest quality standards.The ideal...
-
Certified Nursing Assistant
3 weeks ago
Littleton, Colorado, United States Stellar Senior Living Full timeJob Title: Certified Nursing AssistantAt Stellar Senior Living, we're seeking a compassionate and skilled Certified Nursing Assistant to join our team. As a CNA, you'll play a vital role in providing exceptional care and support to our residents.Key Responsibilities:Assist residents with daily living activities, such as bathing, dressing, and groomingProvide...
-
Certified Nursing Assistant
5 days ago
Littleton, Colorado, United States Brookdale Senior Living Full timeJob Summary:We are seeking a compassionate and skilled Certified Nursing Assistant to join our team at Brookdale Senior Living. As a CNA, you will play a vital role in providing personalized care and support to our residents, ensuring their physical, emotional, and social needs are met.Key Responsibilities:Assist residents with daily living activities, such...
-
Food Service Associate
1 month ago
Littleton, Colorado, United States Civitas Senior Living Full timeFood and Beverage Attendant / Server OpportunityWe are seeking a dedicated and enthusiastic Food and Beverage Attendant / Server to join our team at Civitas Senior Living. As a key member of our hospitality team, you will provide exceptional service to our residents and guests, ensuring a warm and welcoming dining experience.Key Responsibilities:Deliver...
-
Senior Premier Relationship Manager
1 month ago
Littleton, Colorado, United States Bank of Montreal Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior Premier Relationship Manager to join our team at Bank of Montreal. As a key member of our Premier Services team, you will be responsible for managing and growing an assigned portfolio of mass affluent clients across multiple branch locations.Key ResponsibilitiesAct as the primary client...
-
Residential Mortgage Sales Specialist
2 months ago
Littleton, Colorado, United States Wells Fargo Full timePosition OverviewAs a Residential Mortgage Sales Specialist, you will engage in the process of acquiring residential mortgage loans from diverse channels. Your primary focus will be on delivering high-quality loan products that adhere to compliance standards while ensuring exceptional customer service.Key ResponsibilitiesDevelop and maintain strong...
-
Food and Beverage Service Associate
1 week ago
Littleton, Colorado, United States Civitas Senior Living Full timeUnlock a Rewarding Career in Food and Beverage ServiceAt Civitas Senior Living, we're passionate about delivering exceptional dining experiences to our community residents and guests. As a Food and Beverage Service Associate, you'll play a vital role in ensuring our guests receive top-notch hospitality in a team-oriented setting.Key...
Senior Specialist in Regulatory Compliance
2 months ago
At Terumo Blood and Cell Technologies, our dedicated team of over 7,000 professionals is committed to enhancing the lives of patients globally. For Terumo, for Everyone, Everywhere.
We specialize in the development of medical devices and related products designed for the collection, separation, manufacturing, and processing of blood and cellular components. Our innovative solutions positively impact patient care every moment of every day, and we are devoted to expanding our reach to serve more patients. Advancing healthcare with heart.
As a leader in the industry, Terumo Blood and Cell Technologies offers a collaborative environment, exceptional benefits, and a unique culture that fosters growth and teamwork. Join us in shaping the future of healthcare.
We are currently seeking a highly qualified Principal Regulatory Affairs Specialist to spearhead our submissions process for FDA, Health Canada, and/or EU MDR. In this pivotal role, you will utilize your extensive knowledge to navigate the regulatory landscape, ensuring the successful approval of our cutting-edge healthcare solutions. Your key responsibilities will include:
Key Responsibilities:
- Serve as a recognized authority within the organization, possessing a comprehensive understanding of various functions.
- Oversee the complete lifecycle of multiple intricate products and/or projects concurrently.
- Act as a liaison, fostering positive relationships with regulatory agencies throughout the development phases (Pre-Submissions, Submissions, Post Market).
- Develop and implement solutions for complex challenges that may impact diverse business functions.
- Identify issues and enhance existing methods and techniques, potentially proposing new strategies.
- Maintain expertise in global regulatory requirements; monitor regulatory changes and communicate their implications to the organization.
- Represent specific business sectors or regions as the primary contact; engage with management teams and regulatory authorities.
- Review device labeling, promotional materials, and product modifications for compliance with global regulations; analyze and recommend necessary adjustments.
- Interpret and suggest modifications to operational policies that may influence overall objectives and long-term goals.
- Evaluate staff submissions for adequacy, content quality, and consistency.
- Author comprehensive submissions/dossiers.
- Provide technical guidance and regulatory training to other Regulatory Associates and cross-functional teams.
- Exhibit leadership qualities that combine regulatory expertise with business insight and a positive corporate attitude.
Education:
Bachelor's degree in physical/biological sciences or engineering preferred, or an equivalent combination of education and experience. A Master's in Regulatory Affairs or an MBA is also considered valuable.
Experience:
A minimum of 10 years in Regulatory Affairs is required.
- Experience in clinical or statistical roles is preferred.
- PMA experience is advantageous.
- Expert knowledge of regulatory issues across multiple product lines or geographies.
- Proven success in managing regulatory submissions, including CE Mark for Class II-III products, IDEs, INDs, 510(k)s, NDAs, and ANDAs.
- Advanced understanding of medical device regulations such as CFR 820, ISO 13485, ISO 62304, and familiarity with pharmaceutical or biologic regulations is beneficial.
- Ability to comprehend engineering, software development, chemistry, and science principles to collaborate effectively with diverse teams.
- Proactive in seeking relevant legislation and competitive information on product lines.
- Resourceful and results-driven, capable of tackling new challenges across various business areas.
- Decisive and results-oriented; timely decision-making is crucial to mitigate compliance risks and avoid delays in product launches.
- Strong analytical and creative problem-solving skills.
- Experience in negotiation, listening, persuasion, collaboration, and analytical judgment.
- Proficient in relevant PC software applications.
- Excellent verbal and written communication skills.
An equivalent competency level acquired through a combination of these qualifications may be considered.
Certifications:
Regulatory Affairs Certification (RAC) is preferred.
Location:
Remote or Lakewood, Colorado.
Travel:
Some travel may be required (up to 5%).
Physical Requirements:
- Typical office environment requirements include reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting of up to 20 pounds.
- The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Target Pay Range: $121,200.00 to $151,000. Salary will be determined based on education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data.
Bonus:
Target Bonus on Base: 10.0%
At Terumo Blood and Cell Technologies, we offer competitive total reward packages that include compensation, benefits, and recognition programs designed to support your well-being and work-life balance. Our extensive benefits offerings include multiple group medical, dental, and vision plans, a robust wellness program, life insurance, and disability coverage, along with various voluntary programs. We also provide a 401(k) plan with matching contributions and vacation and sick time programs for associates. Our commitment is to safeguard the personal welfare of our associates and their families while helping them achieve their personal goals.
