Public 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
Job Overview 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 reg... Show more
We’re more than just a team – we’re a community dedicated to making a difference every day.At Olympia Hospitality and Hilton Garden Inn - Durham/Medical Center, we create a fun, supportive environm... Show more
FuntoNetwork is seeking a Project Manager for upcoming project opportunity: 179-2627-740-BOIL_REP_NMS_SHS.Durham Public Schools wishes to purchase: Project scope: Remove existing boilers, boiler pu... 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
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
Disaster Recovery / Grant Management / Public Assistance Consultant.Tetra Tech is adding experienced Disaster Recovery / Grant Management / Public Assistance Consultants to our Disaster Recovery te... Show more
Reports To:  Housekeeping Manager.General Purpose: Cleans and prepares guest rooms and public areas by meeting an established standard of cleaning to assure guest satisfaction and the overall ... Show more
Director, Global Regulatory Strategy- Oncology.The Director, Global Regulatory Strategy- Oncology is responsible for developing and executing regulatory strategies for assigned assets in alignment ... 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
Expert Contributor - Certified Public Accountant (CPA).Task-Based Independent Contractor Opportunity.We're looking for CPA-credentialed accounting and finance experts who can design and solve chall... Show more
Public Health Nurse Supervisor (School Health) - 40001142.Durham County Government employs approximately 1,900 employees that work towards providing needed services throughout the community.With a ... Show more
Senior Program Coordinator Hart Leadership Program, Sanford School of Public Policy.Work Arrangement: On-Site Location: Durham, NC, US, 27710 Personnel Area: UNIVERSITY.Duke University was created ... 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
The purpose of this position is to serve as a Contract Specialist for the US Department of Veterans Affairs with the responsibility for performing professional work involving procurement of supplie... Show more
Medical Director, Clinical Development - MRD Portfolio (Solid Tumors).Labcorp Oncology is seeking a Medical Director, Clinical Development - MRD Portfolio (Solid Tumors) to join our team in Durham,... Show more
Disaster Recovery / Grant Management / Public Assistance Consultant.Tetra Tech is adding experienced Disaster Recovery / Grant Management / Public Assistance Consultants to our Disaster Recovery te... Show more
Note : This is an educational program, not a job.Successful completion of the program does not guarantee employment but will equip you with valuable skills for the public health job market.Looking ... Show more
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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