Senior Regulatory Affairs Specialist
BioTalent
Core Responsibilities
- Manage and resolve regulatory information requests by delivering accurate, complete, and audit-ready data packages aligned with global regulatory expectations.
- Conduct structured regulatory risk assessments, perform impact analyses on design and manufacturing changes, and communicate mitigation strategies to cross-functional engineering, quality, and clinical teams.
- Support end-to-end regulatory submissions through detailed reviews of product labeling, clinical and human-factors study protocols, verification/validation documentation, and quality system records.
- Lead development of global regulatory pathways by coordinating with international regulatory counterparts to execute product registrations, renewals, and maintenance activities across multiple regions.
- Ensure alignment with internal quality system requirements by authoring and updating controlled procedures, work instructions, and regulatory-impact documentation.
- Uphold organizational standards for compliance, data integrity, engineering collaboration, and technical accountability.
- Contribute technical expertise to additional regulatory or quality initiatives as assigned.
- Bachelor's degree in a scientific, engineering, or regulated-industry discipline.
- 5+ years of experience in regulatory affairs or quality engineering within the medical device sector, including
- Working knowledge of U.S. regulatory and quality frameworks (e.g., medical device regulations, quality system requirements, and applicable FDA/industry standards spanning clinical practice, laboratory practice, and design controls).
- Ability to support limited domestic or international travel (approx. 15%).
- Demonstrated capability to deliver regulatory leadership throughout the product lifecycle, including regulatory strategy development, design change assessment, submission planning, and documentation review.
- Strong technical writing proficiency with experience authoring structured regulatory submissions for diverse global markets.
- Expertise using productivity and project-management software to manage timelines, technical documentation, and cross-functional deliverables.
- Proven communication and collaboration skills, enabling effective interface with engineering, quality, clinical, and manufacturing functions.
- Strong organizational capability with the discipline to manage multiple technical workstreams concurrently.
- Experience supporting global regulatory operations and coordinating with geographically distributed teams.
- Regulatory Affairs Certification (RAC) is preferred.
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Affairs Specialist in Wilmington, NC vacancy
- Ready to get your automotive career moving? At Premium Velocity Auto/ Jiffy Lube (PVA), your State Motor Vehicle Inspector's License will make your career and earning potential limitless! We are seeking a Licensed State Motor Vehicle Inspector/Lube Technician...SuggestedFull timeTemporary workLocal areaFlexible hours
Jiffy Lube
Leland, NC3 days ago - Join Our Team At Premium Velocity Auto / Jiffy Lube (Pva) Ready to accelerate your automotive career? At Premium Velocity Auto / Jiffy Lube (PVA), your State Motor Vehicle Inspector License unlocks significant growth and earning potential. Job Summary PVA (Jiffy...SuggestedFull timeLocal areaFlexible hours
Premium Velocity Auto LLC
Wilmington, NC2 days ago - ...Job Description A well-respected client is seeking a TAX SENIOR due to the growth in their firm. Are you an experienced individual with a knack for numbers? Then look no further, because we have the perfect opportunity for you! As a Tax Senior, you will be...Senior
gpac
Wilmington, NC3 days ago - ...Job Description A well-respected client is seeking a TAX SENIOR due to the growth in their firm. Are you an experienced individual with a knack for numbers? Then look no further, because we have the perfect opportunity for you! As a Tax Senior, you will be...Senior
gpac
Wilmington, NC2 days ago - ...Job Description A well-respected client is seeking a TAX SENIOR due to the growth in their firm. Are you an experienced individual with a knack for numbers? Then look no further, because we have the perfect opportunity for you! As a Tax Senior, you will be...Senior
gpac
Wilmington, NC17 hours ago - Position Summary: Oversees employees and directs operations of the hearing center. Participates in licensed hearing aid dispenser duties. Provides a high level of member service. For additional information about pay ranges, click here. We offer a comprehensive package ...SeniorTemporary work
Elijahhouseliving
Wilmington, NC2 days ago - ...Senior Foreclosure Attorney The Senior Foreclosure Attorney will report to the Managing Partner of Northeast Foreclosure and take primary... ..., cost reduction, and adherence to legal, client, and regulatory requirements. Analyze loan documentation thoroughly to uncover...SeniorLocal area
HNE
Wilmington, NC2 days ago - Product Manager About the Role We are building an AI-powered platform that enables trusted business verification across global markets. By leveraging advanced language models and machine learning, our technology helps organizations verify businesses, reduce fraud, and ...Senior
Next Ventures
Wilmington, NC5 days ago - ...new Test regions is preferred. · Experience coding in MQ Series & IMS DB is Mandatory. · Experience in Banking Compliance and Regulatory Platform is preferred. · Must have hands-on coding development experience. · Experience with version control. · Ability to...SeniorImmediate start
Galent
Wilmington, NC16 hours ago - Principal - Myrtle Grove Middle School Job Details Terms of Employment: Twelve month work year/Contract/FLSA Exempt Starting Salary and/or Grade: State principal salary schedule with local supplement and full benefits. Position Type: Full-time Job ID: 5750876 Application...Full timeContract workLocal area
Young World Physical Education
Wilmington, NC1 day ago - ...Time Wilmington, NC, US 21 days ago Requisition ID: 1094 Relationships Direct report – Director of Preconstruction Role Purpose The Senior Estimator is responsible for preparing budgets, estimates, and pre-bid packages for construction projects. Responsibilities also...SeniorFull timeFor subcontractorWork at office
Thomas Construction Group
Wilmington, NC2 days ago - ...Senior Underwriter The Senior Underwriter is responsible for evaluating and determining the eligibility of loan applications. Responsibilities include analyzing and verifying loan applications, evaluating risks, and making loan eligibility decisions. The Senior Mortgage...SeniorRemote work
Primis Financial Corp.
Wilmington, NC3 days ago $159k - $182k
...is seeking Initial License Trainees (ILT) to become a licensed Senior Reactor Operator (SRO) supporting Braidwood Nuclear Power Sation... ...training the candidate will be fully licensed by the Nuclear Regulatory Commission (NRC) to supervise the licensed activities of licensed...SeniorHourly payTraineeshipRelocation packageShift workConstellation Energy
Wilmington, NC5 days ago- ...Senior Staff Accountant The Senior Staff Accountant leads key components of the monthly close, financial reporting, and general ledger management while ensuring compliance with GAAP and organizational policies. This role exercises independent judgment, performs complex...SeniorFull timeWork at officeFlexible hours
Lower Cape Fear LifeCare
Wilmington, NC2 days ago - ...Micro1 is looking for a Legal Specialist to join their remote team. This role requires deep expertise in legal principles and contract... ...support litigation efforts, and assist in ensuring compliance with regulatory standards. Ideal candidates must possess strong communication...Contract workRemote work
Micro1
Leland, NC5 days ago $110k - $150k
...Job Title – Senior Trust Officer Help shape the future of Trust Administration. Our client, a cutting-edge trust company, is currently seeking a Senior Trust Officer for their Wilmington, DE location to deliver high-quality service and solutions to their clients....SeniorTPG Staffing LLC
Wilmington, NC2 days ago- ...GARNEY CONSTRUCTION A Senior Project Manager position is available at Garney. To be considered for this position you must have previous progressive construction experience. WHAT YOU WILL BE DOING Manage and develop a team of Project Managers Review cost...SeniorRelocationFlexible hours
Garney Construction
Wilmington, NC1 day ago $120k - $150k
...with your recruiter to learn more. Base pay range $120,000.00/yr - $150,000.00/yr Job details: Our client is looking for a Senior Developer! 100% remote - must be able to obtain security clearance. Salary: $120,000 - $150,000 per year A Bit About Us We are...SeniorLocal areaRemote workJobot
Wilmington, NC18 hours ago$39.2 - $66.7 per hour
...opportunities for individuals who want to join the worldwide leader in cloud banking. nCino’s Legal team is seeking an experienced Senior Corporate Paralegal to provide senior-level, best-in-class legal support to attorneys and business stakeholders across the organization...SeniorContract workWork at officeLocal areaWorldwidenCino
Wilmington, NC5 days ago$107.9k - $183.4k
## Senior Product DesignerApplylocations: Wilmington, NCtime type: Full timeposted on: Posted Yesterdayjob requisition id: R6271nCino offers exciting career opportunities for individuals who want to join the worldwide leader in cloud banking.nCino is looking for a Senior...SeniorLocal areaWorldwidenCino
Wilmington, NC4 days ago$19 per hour
*$500.00 SIGN ON BONUS* Further details upon interview Location : Carolina Bay at Autumn Hall - 630 Carolina Bay Drive, Wilmington, NC 28403. Schedule : Full time schedule. Hours and days may vary, including weekends. Further details upon interview. Requirement : 2 years...SeniorHourly payFull timePart timeLocal areaRemote workRelocation packageFlexible hoursCompass Group
Wilmington, NC16 hours ago$51.2k - $64k
...writing. Ability to read, understand and interpret difficult materials with complicated information that may contain excerpts from regulatory and/or legal documents. Ability to keep office records and to prepare accurate reports from file sources. Ability to...SeniorFull timeWork at officeTown of Leland
Leland, NC3 days ago- ...delivery of healthcare services to the communities we serve. As a Senior Accountant, you'll play a key role in strengthening the... ...healthcare industry requirements. Support grant reporting, regulatory reporting, and other compliance-related activities as needed....SeniorLocal area
Jobot
Wilmington, NC2 days ago - ...Description We are currently accepting applications for experienced Land Development Civil Engineering Project Manager or Senior Project Managers to join our Land Development group in our Wilmington, NC office location. Projects range from multi-family...SeniorWork experience placementWork at officeFlexible hours
Timmons Group
Wilmington, NC3 days ago - ...process validation as well as preparation of CMC sections for regulatory submissions and updates. Essential Functions of the Job (Key... ...by working with Quality Assurance and Regulatory Affairs, negotiate effective supply/technical agreements. Work closely...SeniorContract workWork experience placement
- ITAC serves Process & Industrial clients with integrated engineering and construction services for complex capital projects. We also offer specialty services including power systems services and products, custom machine fabrication, and fall protection services and equipment...SeniorTemporary workInternship
ITAC
Wilmington, NC4 days ago $119k - $158k
...directly influences winning strategies, customer trust, and the future of GE Aerospace's Defense Engines and Services business. As a Senior Product Cost Estimator, you will play a highly visible role in shaping competitive, compliant, and high-quality cost estimates for...SeniorContract workRemote workGE Aerospace
Wilmington, NC5 days ago$80k - $95k
...Description Job Description: Title: Senior Account Manager - Commercial Lines Hybrid Preferred: 1-2 days in Columbia, SC office OR Fully Remote : for applicants in Eastern and Central Time Zones Book Focus: Generalist, Contractors | Requirement...SeniorFor contractorsRemote workInsurance Office of America
Wilmington, NC2 days ago$50k - $60k
...Description Job Description: Title: Senior Account Associate - Commercial Lines Supporting: Longwood, FL | Hybrid Preferred: 2 days in office OR Fully Remote: candidates in Alabama, Florida, Georgia, North Carolina, South Carolina, Tennessee Book...SeniorContract workRemote workInsurance Office of America
Wilmington, NC17 hours ago$90.23k
45032BR Requisition ID: 45032BR Business Unit: COR Job Description: CDM Smith is seeking a Senior Financial Analyst to join our Corporate FP&A Team! This role supports financial planning and analysis projects and initiatives for the enterprise, including...SeniorFull timeH1bRemote workCDM Smith
Wilmington, NC2 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Affairs Specialist. Be the first to apply!
Related searches
- senior compensation manager Wilmington, NC
- senior vice president of operations Wilmington, NC
- senior manager creative operations Wilmington, NC
- senior storage engineer Wilmington, NC
- senior hvac project manager Wilmington, NC
- senior cybersecurity engineer Wilmington, NC
- senior financial analyst fp&a Wilmington, NC
- senior manager accenture Wilmington, NC
- senior payroll accountant Wilmington, NC
- senior marketing project manager Wilmington, NC