Public affairs specialist • 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
Assistant Director, Student Affairs.Work Arrangement: On-Site Location: Durham, NC, US, 27710 Personnel Area: UNIVERSITY Date: Jul 8, 2026.Duke University was created in 1924 through an indenture o... Show more
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the imm... Show more
Chemistry, Manufacturing, and Controls (CMC) Regulatory Strategy Leader.At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.Our R&D focuses on discovering and d... 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
Executive Director, Clinical Development & Medical Affairs.The Executive Director, Clinical Development & Medical Affairs is responsible for leadership and oversight of the clinical development and... Show more
Key Responsibilities (Essential Duties and Functions): This list of duties and responsibilities is not all-inclusive and may expand to include other duties and responsibilities based on business ne... Show more
Direct, oversee and manage large, complex, regulatory projects, ensuring quality deliverables on time and within budget.May act as a Project Manager for a large and complex stand-alone project or p... 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
Director (Senior Director), Regulatory Affairs.Shattuckians are a diverse group of physicians, scientists, drug developers and protein engineers that are linked through our shared desire to build t... 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
Job Description As a Hub Specialist, you'll bring your organizational skills and process-driven mindset to support critical hub operations, driving efficiency, fostering teamwork, and mainta... 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 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
Director / Senior Director, Regulatory Affairs.The company is seeking a Director or Senior Director of Regulatory Affairs with the final title set according to the selected candidate's background ... Show more
The Treasury Specialist plays a critical role in supporting the company's cash management, accounts receivable, and financial documentation functions.This position is responsible for maintaining ac... Show more
Regulatory Affairs Specialist (CMC).The Regulatory Affairs Specialist is responsible for supporting global regulatory activities related to product development, registration, and lifecycle manageme... Show more
At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community.No matter where your talents lie, join us and disc... Show more
Director / Senior Director, Regulatory Affairs.The company is seeking a Director or Senior Director of Regulatory Affairs — with the final title set according to the selected candidate's background... Show more
About the role We are hiring expert Evaluators in **Government / public administration** to review and assess AI-generated work products (documents, spreadsheets, and slide decks) for accuracy, rig... Show more
The average salary range is between $ 73,272 and $ 105,818 year , with the average salary hovering around $ 89,545 year .
The average salary range is between $ 63,384 and $ 130,070 year , with the average salary hovering around $ 85,830 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.
