Current jobs related to Principal Regulatory Affairs Consultant - Durham, North Carolina - Bioventus

  • Regulatory Affairs Specialist

    4 weeks ago

    Durham, North Carolina, United States GSK Full time

    About the RoleWe are seeking a highly motivated Regulatory Affairs professional to join our CMC (Chemistry, Manufacturing and Controls) Regulatory Affairs Group. As a Regulatory Project Manager (CMC), you will be responsible for providing CMC support to a defined portfolio of marketed drug substances and products for global markets.Key...

  • Regulatory Affairs Director

    4 weeks ago

    Durham, North Carolina, United States SHATTUCK LABS, INC. Full time

    Job Title: Associate Director, Regulatory AffairsAbout the Role:The Associate Director, Regulatory Affairs will play a key role in contributing to the development and implementation of global regulatory strategies for assigned programs. This individual will be responsible for ensuring compliance with local and regional requirements, as well as company...

  • Director of Regulatory Affairs

    4 weeks ago

    Durham, North Carolina, United States GlaxoSmithKline Full time

    Job Title: Director of Regulatory Affairs, CMCAre you a seasoned regulatory professional looking for a challenging role where you can make a significant impact? We are seeking a highly skilled Director of Regulatory Affairs, CMC to join our team at GlaxoSmithKline.About the Role:This is an exciting opportunity to lead key strategic CMC regulatory activities...

  • Contract and Regulatory Affairs Specialist

    7 days ago

    Durham, North Carolina, United States MedPharm Full time

    Job SummaryWe are seeking a highly experienced Contract and Regulatory Affairs Specialist to join our dynamic legal team at MedPharm in a fast-paced, high-volume CDMO environment. This individual will have a demonstrated history of working within the pharmaceutical, biotechnology, and CRO industries, with a strong background in contract management, clinical...

  • Head of US Crop Protection Regulatory Affairs

    2 weeks ago

    Durham, North Carolina, United States BASF Corporation Full time

    Job Title: Head of US Crop Protection Regulatory AffairsWe are seeking a highly skilled and experienced professional to lead our US Crop Protection Regulatory Affairs team. As a key member of our Agricultural Solutions division, you will be responsible for ensuring compliance with all applicable regulatory standards and record-keeping requirements.Key...

  • Director, Regulatory Affairs CMC

    1 week ago

    Durham, North Carolina, United States Asklepios Biopharmaceutical Full time

    Job SummaryThe Director, Regulatory Affairs CMC is responsible for leading the regulatory CMC strategy and coordinating regulatory operations and logistics for all assigned projects. This role will ensure the timely registration of gene therapy product candidates in the US and internationally.Key ResponsibilitiesDevelop and implement comprehensive regulatory...

  • Regulatory Coordinator Senior

    2 weeks ago

    Durham, North Carolina, United States Duke Health Full time

    Job Title: Regulatory Coordinator SeniorJob Summary:Duke Health is seeking a highly skilled Regulatory Coordinator Senior to lead the day-to-day regulatory and safety operations of a regulatory team conducting multiple, complex oncology clinical trials and research studies. The successful candidate will have a strong background in regulatory affairs,...

  • System Director for Regulatory and Accreditation

    2 weeks ago

    Durham, North Carolina, United States Duke Health Full time

    Job SummaryDuke Health is seeking a highly skilled and experienced System Director for Regulatory and Accreditation to join our team. This role will be responsible for coordinating and ensuring ongoing compliance with accreditation and other regulatory activities for the hospitals and clinical entities in the Duke University Health System (DUHS).Key...

  • Regulatory Operations Manager

    2 months ago

    Durham, North Carolina, United States Duke Health Full time

    Senior Regulatory Coordinator RoleJob Summary:We are seeking a highly skilled Senior Regulatory Coordinator to lead the regulatory and safety operations of a team conducting oncology clinical trials and research studies for our Cancer Institute's Clinical Research Program at Duke Health.Key Responsibilities:Oversee day-to-day regulatory operations for...

  • Principal Engineer

    4 days ago

    Durham, North Carolina, United States City of Durham Full time

    Job Title: Principal EngineerJob Summary:We are seeking a highly skilled Principal Engineer to join our team at the City of Durham. As a Principal Engineer, you will be responsible for managing water and wastewater capital projects from inception to completion. This includes scope and budget development, procurement of consultants/contractors, contract...

  • Regulatory Coordinator

    2 weeks ago

    Durham, North Carolina, United States Duke Health Full time

    Job Summary We are seeking a highly skilled Regulatory Coordinator to join our team at Duke Health. The successful candidate will be responsible for performing study-specific regulatory and safety reporting processes across multiple studies in accordance with appropriate regulations, institutional policies, and Standard Operating Procedures (SOPs). Key...

  • Principal Engineer: Collection Systems

    2 weeks ago

    Durham, North Carolina, United States City of Durham, NC Full time

    Job Title: Principal Engineer: Collection SystemsJoin the City of Durham's Department of Water Management as a Principal Engineer: Collection Systems. As a key member of our team, you will be responsible for managing and overseeing the design, construction, and operation of our collection systems.Key Responsibilities:Manage and oversee the design,...

  • Principal Engineer: Collection

    1 week ago

    Durham, North Carolina, United States City of Durham Full time

    Job Title: Principal Engineer: CollectionWe are seeking a highly skilled Principal Engineer to join our team in the Collection and Distribution Systems department. As a Principal Engineer, you will be responsible for managing and overseeing the design, construction, and operation of our water and wastewater collection and distribution systems.Key...

  • Principal Engineer Water Treatment

    2 weeks ago

    Durham, North Carolina, United States City of Durham, NC Full time

    Job Title: Principal Engineer Water TreatmentWe are seeking a highly skilled Principal Engineer Water Treatment to join our team at the City of Durham, NC. As a key member of our Water Management department, you will be responsible for managing water treatment plant projects from inception to completion.Key Responsibilities:Manage water treatment plant...

  • Principal Water Resources Engineer

    4 days ago

    Durham, North Carolina, United States City of Durham, NC Full time

    Job Title: Principal Water Resources EngineerCity of Durham, NC is seeking a highly skilled Principal Water Resources Engineer to join our team. As a key member of our Water Management Department, you will be responsible for managing and overseeing various water resources projects, ensuring compliance with regulatory requirements and providing excellent...

  • Principal Engineer: Water and Wastewater Treatment

    3 weeks ago

    Durham, North Carolina, United States City of Durham Full time

    Job Title: Principal Engineer: Water and Wastewater TreatmentJoin the City of Durham's Department of Water Management as a Principal Engineer: Water and Wastewater Treatment. As a key member of our team, you will be responsible for managing water and wastewater treatment projects from inception to completion.Responsibilities:Manage water and wastewater...

  • Principal Engineer: Water and Wastewater Treatment

    7 days ago

    Durham, North Carolina, United States City of Durham, NC Full time

    Job Title: Principal Engineer: Water and Wastewater TreatmentCity of Durham, NC is seeking a highly skilled Principal Engineer to join our team. As a Principal Engineer, you will be responsible for managing water and wastewater treatment projects from inception to completion. This includes scope and budget development, procurement of consultants/contractors,...

  • Principal Engineer: Water and Wastewater Treatment Specialist

    1 week ago

    Durham, North Carolina, United States City of Durham Full time

    Job SummaryWe are seeking a highly skilled Principal Engineer to join our team in Durham, NC. As a key member of our Water Management Department, you will be responsible for managing complex water and wastewater treatment projects from inception to completion.Key Responsibilities:Manage project scope, budgets, and schedulesDevelop and administer...

  • Principal Engineer: Collection

    4 weeks ago

    Durham, North Carolina, United States City of Durham Full time

    Job Title: Principal Engineer: CollectionJob Summary:The City of Durham is seeking a highly skilled Principal Engineer: Collection to join our team. As a key member of our Water Management Department, you will be responsible for managing and overseeing the design, construction, and operation of our collection and distribution systems.Responsibilities:Manage...

  • Principal Statistical Programmer, PKPD

    3 days ago

    Durham, North Carolina, United States IQVIA Full time

    We are seeking a highly skilled and motivated Principal Statistical Programmer with expertise in pharmacokinetics (PK) and pharmacodynamics (PD) to join our dynamic team.Position Overview:As a Principal Statistical Programmer with a specialized focus on PK/PD, you will play a pivotal role in the design, execution, and analysis of clinical trials to support...

Principal Regulatory Affairs Consultant

2 months ago

Durham, North Carolina, United States Bioventus Full time
Are you prepared to contribute to a more active world?

At Bioventus, we prioritize the growth and development of our team members. We believe in investing in our people and encouraging them to reach their full potential. Our diverse workforce is valued for its unique perspectives and contributions, and our leadership is committed to listening and fostering collaboration. Our collective success is built on teamwork and shared objectives. Join a global team dedicated to helping patients lead active lives.

The Senior Regulatory Affairs Specialist plays a crucial role in providing comprehensive regulatory support for new product approvals and the renewal of existing products. This includes the formulation of regulatory requirements and the preparation of submissions. The Senior Specialist serves as the Subject Matter Expert during external regulatory evaluations. Key responsibilities encompass ensuring compliance with relevant regulations, standards, and established corporate policies. (This position offers a hybrid work model.)Key Responsibilities
  • Prepare and submit applications such as 510(k), PMA Supplements, and Technical Documentation to secure product approvals for new offerings and maintain current registrations worldwide.
  • Develop and uphold Technical Files in accordance with MDD 93/42/EEC and Technical Documentation compliant with EU MDR 2017/745.
  • Engage with Regulatory Agencies regarding submissions and product modifications, including manufacturing, design, and new product initiatives.
  • Act as the Subject Matter Expert to represent Regulatory Affairs during internal and external audits conducted by regulatory bodies.
  • Contribute to cross-functional project teams as assigned.
  • Evaluate protocols and reports for scientific integrity and regulatory compliance, providing expert guidance to cross-functional teams.
  • Conduct Regulatory Assessments for design, manufacturing, and labeling changes to ensure adherence to regulations and standards in all registered markets.
  • Research regulatory requirements and prioritize tasks while adhering to project timelines.
  • Offer guidance and oversight to team members regarding regulatory compliance matters.
  • Review marketing materials for alignment with applicable regulations and company policies.
  • Perform additional duties as assigned by management.
Qualifications
  • Bachelor's Degree in Life Sciences, Engineering, or a related field.
  • A minimum of 5 years of experience in Regulatory Affairs, ideally within the medical device sector.
  • Experience with registrations in FDA, EU, Health Canada, Brazil, Japan, and Australia.
  • Strong ability to create clear, concise, and timely oral and written communications and reports.
  • Exceptional communication skills, both verbal and written, with personnel at all levels.
  • Detail-oriented with strong organizational capabilities.
  • Familiarity with electromechanical and implantable medical devices and regulations concerning human tissue is advantageous.
  • Proven ability to collaborate effectively with employees, management, departments, and cross-functional teams to achieve performance goals and support the company's mission and vision.
Are you the exceptional talent we seek?

We invite you to submit your resume and cover letter for consideration.

Bioventus is dedicated to cultivating an inclusive and diverse workforce, fostering a strong sense of belonging. We believe that diversity enhances our organization, and we take pride in collaborating with top talent from various backgrounds. In the spirit of inclusivity, we welcome qualified applicants 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.