Location: Cleveland, OH
Company: Cleveland Diagnostics
Novo, PMA, PMA supplements, and IVDR Technical Files) supporting new product development and throughout the product lifecycle. You will be responsible for leading the development and implementation of regulatory initiatives that ensure our organization is compliant with relevant laws and regulations.
You'll collaborate cross-functionally with internal teams, including clinical, R&D, quality assurance, manufacturing and external consultants to help us stay ahead of the curve in an ever-changing regulatory landscape. Essential Duties and Responsibilities Develop and implement regulatory strategies for new and existing products to support approval/clearance of products domestically and licensing
and registration internationally throughout the product lifecycle. Prepare, review, and submit regulatory packages (510(k), De Novo, PMA, PMA supplements, and IVDR Technical Files) supporting new product development and throughout the product lifecycle.
Maintain product approvals and complete all necessary notifications, supplements, amendments, listings, and yearly reports for products on a worldwide basis. Develop and implement RA strategy for product development and design changes. This may include counselling R&D/Tech Support project team leaders as to product design and required field and in-house studies to support regulatory strategies as well as regulatory requirements for manufacturing
process changes. Collaborate cross-functionally with internal teams, including clinical, R&D, quality assurance, manufacturing, to prepare, review, and submit high-quality regulatory submissions, including PMA, 510k, and other relevant applications, ensuring compliance with regulatory requirements and timelines.
Research and analyze information related to regulatory compliance and develop appropriate strategies to ensure compliance. Monitor and track changes in the regulatory environment and provide timely updates to key stakeholders. Develop and implement policies and procedures for regulatory compliance. Develop and maintain relationships with regulatory authorities and other stakeholders.
Represent the company at meetings and conferences related to regulatory affairs. Provide support and guidance to other departments on regulatory affairs matters. Perform all other duties as assigned Education and/or Work Experience Requirements: Bachelor's degree in science or medical related field Certification such as RAC from the Regulatory Affairs Professionals Society preferred. 10+ years of regulatory affairs experience in the IVD/Medical Device industry supporting regulatory strategies and preparing FDA or ex-US submissions of in vitro diagnostic (IVD) products, such as 510(k)s, and/or PMAs submissions, and/or technical files Experience with e CTD requirements or electronic submissions.
Hands-on experience in the preparation of regulatory and technical submissions, reports and documentation or in the implementation of quality management systems (e. g. ISO 13485, ISO 9001, 21 CFR 820, IVDR, MDSAP or equivalent), preferably in the medical device or diagnostics environment. Extensive knowledge of US FDA device regulations, including, but not limited to FDA regulations regarding medical devices and labeling, c GMPs, etc. Knowledge and ability to develop, review, and approve technical literature and promotional materials to ensure consistency and compliance with domestic promotional regulations.
Must be able to write clear, understandable technical documentation, i. e. regulatory documentation or scientific presentations. Effective written & verbal communication skills Works well in a collaborative & team-oriented environment Ability to manage & prioritize workload effectively Physical Requirements: Offices reachable by elevator but should be able to climb stairs in case elevator out General office noise and HVAC Ability to sit and/or stand and operate a computer and other technology related lab equipment through course of day May be exposed to hazardous chemicals, biohazards, etc.
Other Requirements Basic COVID-19 vaccination is highly recommended Cleveland Diagnostics, Inc. is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. Its portfolio of non-invasive diagnostics will be expanding from prostate cancer to breast cancer and lung cancer. We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee's well-being and happiness as the primary reason for our success.
Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics. Cleveland Diagnostics offers an extremely robust benefits package which includes: 100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage 100% Employer-paid Dental & Vision for entire family No cost for employee coverage for Group Term Life, Short & Long Term Disability 4% retirement contribution Employer match Incentive Performance Plan & Stock Option Program & Commission (Sales Account Execs) Paid Family Leave Program Generous PTO plan & holiday program Flexible work schedule & lucrative employee referral program Salary range may vary by work state/geographical region/territory Easy to get to office location with newly built-out office space Free coffee, snacks and other goodies all day long Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination.
We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law. Applicants can learn more about the company's status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities. PI86f8d330e05b-31181-#######5 Associated topics: analyst, government, hospital, medical center, product market, regulatory, relation, relationship, social media, university relationship
Management & Executive Jobs refer to positions within an organization that involve overseeing operations and making strategic decisions to guide the company towards its objectives. These roles are characterized by leadership responsibilities, high-level planning, and typically require extensive experience. Executives set the vision and goals, while managers ensure that daily activities align with these directives. Such positions often demand strong communication and interpersonal skills, as well as the ability to solve complex problems and adapt to changing business environments.
Management & Executive Jobs refer to high-level positions within an organization that involve overseeing operations, making strategic decisions, and leading teams towards achieving business objectives. Individuals in these roles typically have significant experience and expertise in their respective fields. They are responsible for setting goals, developing policies, and ensuring the effective management of resources. Executive roles often include titles such as CEO, CFO, COO, and department heads, among others. Characteristically, these jobs demand strong leadership skills, excellent communication abilities, and a capacity to think critically and solve complex problems.
quality of food according to policies, procedures, and department requirements. Ensure that food items are stored in a safe, organized, and hazard-free environment. Maintain all serving schedules; ensure that all food items are served per menu specifications in a safe and appropriate manner according to departmental policies and procedures.
Maintain a sanitary department following health and safety codes and regulations. Maintain accurate inventory on a weekly basis according to departmental policies and procedures. May prepare orders as needed per vendor to ensure accurate production for location. Must be knowledgeable in operating an efficient cost effective program. Supervise and evaluate
employees; counsel; promote employee growth, efficiency, morale, and teamwork. At Aramark, developing new skills and doing what it takes to get the job done make a positive impact for our employees and for our customers.
In order to meet our commitments, job duties may change or new ones may be assigned without formal notice. Qualifications Must read, write, and understand verbal instructions Must complete a sanitation course either before or during the first year as a lead Ability to perform basic arithmetic Maintain emotional control under stress Ability to resolve interpersonal situations Strong organizational skills Minimum Education/Certification - High School Diploma/GED This role
may have physical demands including, but not limited to, lifting, bending, pushing, pulling and/or extended walking and standing.
This role may also require uniforms and/or usage of Personal Protective equipment (PPE). Education About Aramark Our Mission Rooted in service and united by our purpose, we strive to do great things for each other, our partners, our communities, and our planet. At Aramark, we believe that every employee should enjoy equal employment opportunity and be free to participate in all aspects of the company. We do not discriminate on the basis of race, color, religion, national origin, age, interaction, gender, pregnancy, disability, interactionual orientation, gender identity, genetic information, military status, protected veteran status or other characteristics protected by applicable law.
About Aramark The people of Aramark proudly serve millions of guests every day through food, facilities, and uniform services in 19 countries around the world. Rooted in service and united by our purpose, we strive to do great things for each other, our partners, our communities, and our planet. We believe a career should develop your talents, fuel your passions, and empower your professional growth. So, no matter what you're pursuing - a new challenge, a sense of belonging, or just a great place to work - our focus is helping you reach your full potential.
Learn more about working here at http: // or connect with us on Facebook , Instagram and Twitter.
Guest Services Support Staff in providing 24 hours a day, 7 days a week coverage. • Coordinates registration functions and transportation for all guests. • Trains Front Desk/Concierge personnel by utilizing training programs established in conjunction with Aramark, and conference center clients.
• Oversees front desk and concierge's tasks to ensure world class service is provided in the following areas: • Check in and check out functions • Ensures proper execution of Lobby Ambassador Program. • Guest orientation of the local area and the conference center facilities • Proper telephone service technique and PBX operation • Handling of guest mail, messages and special deliveries • Coordinating
reservations for guest transportation • Full understanding and utilization of the property management system • Familiarization with night audit function • Assisting all guests in any way possible including following up on guest concerns in a timely manner.
• Maintaining a limited supply of sundries and restocks as necessary. • Issuing and monitoring safe deposit boxes • Opening and closing of support staff cashier banks. • Design and implement training programs to ensure that all staff are well-versed in daily job functions, safety awareness, and Aramark policies and procedures. • Responsible for ordering, storing and inventory of all supplies necessary to perform daily operations. •
Communicate closely with all departments to ensure a seamless guest experience.
• Establish, implement, and follow all emergency procedures. • Perform any or all other duties as assigned by Guest Services Manager At Aramark, developing new skills and doing what it takes to get the job done make a positive impact for our employees and for our customers. In order to meet our commitments, job duties may change or new ones may be assigned without formal notice. Qualifications • Requires a positive attitude, strong work ethic, and a commitment to providing world-class service to the client, guests, and co-workers. • A strong knowledge of personal computers is essential.
• Experience in all facets of providing guest services. • Must be able to lead, motivate, and communicate effectively with others. • Strong organizational abilities. • Preferably two years in hospitality services or like environment performing like duties as Guest Services or Concierge’s supervisor. • Must be able to read, write, and clearly speak English This role may have physical demands including, but not limited to, lifting, bending, pushing, pulling and/or extended walking and standing. This role may also require uniforms and/or usage of Personal Protective equipment (PPE).
Education About Aramark Our Mission Rooted in service and united by our purpose, we strive to do great things for each other, our partners, our communities, and our planet. At Aramark, we believe that every employee should enjoy equal employment opportunity and be free to participate in all aspects of the company. We do not discriminate on the basis of race, color, religion, national origin, age, interaction, gender, pregnancy, disability, interactionual orientation, gender identity, genetic information, military status, protected veteran status or other characteristics protected by applicable law.
About Aramark The people of Aramark proudly serve millions of guests every day through food, facilities, and uniform services in 19 countries around the world. Rooted in service and united by our purpose, we strive to do great things for each other, our partners, our communities, and our planet. We believe a career should develop your talents, fuel your passions, and empower your professional growth. So, no matter what you're pursuing - a new challenge, a sense of belonging, or just a great place to work - our focus is helping you reach your full potential. Learn more about working here at http: // or connect with us on Facebook , Instagram and Twitter.
