Medical affairs • durham nc
Senior Regulatory Affairs Specialist.Are you ready to work for a more active world? At Bioventus, our business depends on developing our people.We invest in you and challenge you to be the best.We ... Show more
Provides general medical care under the direction of a licensed provider to patients in an outpatient clinic setting.This position works directly with a franchised business location.The specific jo... Show more
Medical Assistant/Phlebotomist.We're building a world of health around every individual shaping a more connected, convenient and compassionate health experience.At CVS Health, you'll be surrounded... Show more
Ansible Government Solutions, LLC (Ansible) is currently recruiting Medical Support Assistants (MSA) to support the Durham VA Medical Center located at 508 Fulton St.Working hours are Mon-Fri, 8:00... Show more
Start a rewarding career with Avance Care where your skills make a real difference in patients' lives every day.Join our growing network of 35 practice locations across the Triangle Area (Raleigh-... Show more
Medical Assistant/Phlebotomist.We're building a world of health around every individual shaping a more connected, convenient and compassionate health experience.At CVS Health, you'll be surrounded... Show more
The job details are as follows:.Key Accountabilities / Responsibilities.Direct the company's efforts to build and maintain expertise with specific diseases and clinical/scientific processes to prov... Show more
Sipcam Agro USA is headquartered in Durham, North Carolina, and is owned by Sipcam Oxon Group, an Italian-based company founded in 1946 and recognized worldwide for formulation and manufacturing ex... Show more
Director, Health Promotions, Student Affairs.Work Arrangement: On-Site Requisition Number: 274661 Regular or Temporary: Regular Location: Durham, NC, US, 27710 Personnel Area: UNIVERSITY.Duke Unive... Show more
As a Medical Assistant, reporting to Supervisor, Central Administration, you will be the first contact for patient care, responsible for administrative responsibilities in addition to patient care.... Show more
As a Medical Assistant, reporting to Supervisor, Central Administration, you will be the first contact for patient care, responsible for administrative responsibilities in addition to patient care.... Show more
The Director, Regulatory Affairs develops, implements, leads and supports regulatory strategies for assigned projects in collaboration with various cross-functional teams.The Director, Regulatory A... Show more
Line Management responsibilities for a team of Regulatory staff or may be responsible for the performance of one or more Regulatory Affairs sites.Responsible for the development of regulatory busin... Show more
Senior Regulatory Affairs Strategy Specialist.BD is one of the largest global medical technology companies in the world.Advancing the world of health is our Purpose, and it's no small feat.It takes... Show more
New Hope Urgent Care hiring a Full Time Medical Receptionist /Medical Assistant to :.Greet patients with smiling face.Answer phone calls professionally.Can do vital signs, point of care testing, U... Show more
Eventus WholeHealth delivers an integrated model that provides holistic care for medically vulnerable adults achieving extraordinary outcomes for the people we serve.This care is provided to adults... Show more
We're building a world of health around every individual shaping a more connected, convenient and compassionate health experience.At CVS Health, you'll be surrounded by passionate colleagues who c... Show more
As a Medical Assistant, reporting to Supervisor, Central Administration, you will be the first contact for patient care, responsible for administrative responsibilities in addition to patient care.... Show more
Director, Medical Affairs - Oncology and Hematologic Malignancies.Labcorp is a global leader in laboratory services, providing the insights and answers that help healthcare providers, patients, res... Show more
We are excited to announce an opening for a Medical Assistant.The Medical Assistant (MA) is responsible for providing high-quality, compassionate clinical and administrative support to physicians, ... Show more
The average salary range is between $ 99,656 and $ 220,000 year , with the average salary hovering around $ 150,887 year .
Are you ready to work for a more active world? At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.
Bioventus LLC., seeks Senior Regulatory Affairs Specialist (Durham, NC). Duties include authoring and submitting applications 510(k), PMA Supplements and technical documentation to receive product clearance/approvals for new products and maintain existing registrations globally. Author and maintain technical files compliant to the MDD 93/42/EEC and technical documentation compliant to the EU MDR 2017/745. Communicate with regulatory agencies regarding submissions, and changes of products, including manufacturing, design and new product development. Serve as subject matter expert to represent regulatory during internal audits and external audits by regulatory agencies. Review protocols and reports for scientific validity and compliance to regulatory standards and provide scientific judgement to guide cross functional teams. Perform regulatory assessments for design, manufacturing, and labeling changes to ensure compliance with regulations and standards where the product is registered. Research requirements and set priorities while maintaining project schedules. Provide guidance and oversight to team members related to regulatory compliance. Review marketing literature for compliance with applicable regulations and company policies and procedures.
Required: Master's degree or foreign equivalent in Regulatory Affairs, Pharmaceutical Sciences or related field plus 3 years of experience in the job offered, as Regulatory Engineer or related regulatory affairs position within the medical and/or diagnostic device industry. Must have 3 years of experience with: regulatory assessment of engineering/design change execution. Working with or providing guidance to cross-functional or offshore team in preparation of documents for regulatory agency submissions. Regulatory registrations in at least 3 or more of the following agencies or regions (FDA, EMEA, Canada, LATAM, Japan, Australia). Project management. Preparing and reviewing documentation regarding submissions and product changes of medical devices. Must have experience working with medical device registrations compliant with Medical Device Regulation and EU Medical Device Directive. Hybrid role model position, working 3 days in office and 2 days from within normal commuting distance of the office location. National travel required 25% of the time.
Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms of diversity and take pride in working with top talent from every walk of life. In the spirit of inclusivity, qualified applicants will be considered without regard to age, ethnicity, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion or sexual orientation. All individuals, regardless of personal characteristics, are encouraged to apply.
Innovations for Active Healing that Enhance the Body's Ability to Heal Bioventus is a global leader of innovations for active healing. Through a combination of internal product development, product/business acquisition, and distribution agreements, we will bring to market products which address a growing need for clinically effective, cost efficient, minimally invasive medical treatments, that engage and enhance the body's natural healing processes.
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