Regulatory Affairs Specialist jobs in North Carolina

Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)

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Senior Regulatory Affairs Specialist
  • Safeguard Medical
  • Harrisburg, NC FULL_TIME
  • Description

    The Senior Regulatory Affairs Specialist will be responsible for ensuring compliance with all regulatory requirements for medical devices and pharmaceutical products.


    This position requires a deep understanding of the regulatory landscape and the ability to navigate complex regulatory processes.. This individual will provide a sense of urgency to cross-functional teams assisting with global programs and ensure effective communication with business partners worldwide.  This is a full-time onsite role in Harrisburg, NC until early 2024 when the position will be located in our brand new Huntersville, NC facility. 


    Responsibilities:

    1. Develop and implement regulatory strategies for medical devices and pharmaceutical products.
    2. Stay up-to-date with the latest regulatory requirements and changes in the industry.
    3. Prepare and submit regulatory submissions to regulatory authorities, including FDA, EMA, and other global regulatory bodies.
    4. Review and approve labeling, promotional materials, and product claims to ensure compliance with regulations.
    5. Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.
    6. Conduct regulatory assessments and provide guidance on regulatory requirements for new product development.
    7. Participate in regulatory agency inspections and audits.
    8. Provide training and guidance to internal teams on regulatory requirements and processes.
    9. Monitor and track regulatory submissions and approvals.
    10. Coordinate and manage regulatory activities, including product registrations, renewals, and variations.
    11. Provide regulatory support and guidance to internal stakeholders, including R&D, Quality Assurance, and Manufacturing.
    12. Monitor and assess changes in regulations and communicate potential impact to the organization.
    13. Maintain regulatory documentation and records in accordance with company procedures and regulatory requirements.



    Requirements

    Qualifications:

    1. Bachelor's degree in a scientific or related field. Advanced degree preferred.
    2. Minimum of 4-7 years of experience in regulatory affairs for medical devices and/or pharmaceutical products.
    3. Strong knowledge of FDA regulations, EU MDR, and other global regulatory requirements.
    4. Experience with regulatory submissions, including 510(k), PMA, IDE, NDA, and IND.
    5. Strong understanding of the product development process and ability to assess regulatory impact.
    6. Familiarity with quality management systems and ISO standards.
    7. Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information to both technical and non-technical stakeholders.
    8. Detail-oriented with strong organizational and project management skills.
    9. Strong attention to detail and ability to work in a fast-paced environment.
    10. Ability to collaborate effectively with cross-functional teams.
    11. Regulatory certifications (RAC) are a plus.

    Essential Job Functions

    1. Review labeling, training, and promotional material.
    2. Support product and shipping release.
    3. Maintenance of FDA’s GUDID database.
    4. Maintenance of FDA’s Drug listings and CARES Act Reporting.
    5. Technical file update and reviews.
    6. Review of External Standards.
    7. Support business with government queries and registration documentation requirements.
    8. Review Change Orders and assess regulatory impact of product changes on US and/or International regulatory strategy.
    9. Support post market regulatory compliance activities for US/International product approvals.
    10. Assist with the development and maintenance of regulatory affairs department procedures.
    11. Comply with applicable FDA and international regulatory laws/standards.
    12. Ensure relevant ISO and FDA Export requirements are met, as required.
    13. Performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
    14. Compiles all materials to support submissions, license renewal and annual registrations.
    15. Keeps abreast of regulatory procedures and changes.
    16. Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products.
    17. Customer Service Support.
    18. Proactively drive activities to meet and/or exceed company objectives.
    19. Maintain regulatory files/database and chronologies in good order. 
    20. 20. Manage interactions with distributors, consultants, and/or partners. 
    21. 21. Perform other related duties and responsibilities as assigned.

    Competencies

    1. Ability to perform at high levels in a thriving environment, preferably in the medical device industry or combination products industry.
    2. Knowledge of FDA, MDD, EU MDR.
    3. Knowledge of Pharma.
    4. ISO regulations/standards, including ISO 10993 (requirements for biocompatibility).
    5. RAC certification is a plus.
    6. Ability to focus and achieve scheduled milestones, including contingency planning.
    7. Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization.
    8. Strong team-working and organizational skills with a drive to complete tasks in the face of obstacles and time constraints, and a willingness to collaborate wherever needed.

    Physical Requirements

    Performing the duties of this job regularly involves sitting, standing, walking, hearing/listening, repetitive hand movement, grasping and reaching. Vision requirements include the ability for close vision, to adjust focus, to color code.  

    Mental Requirements

    This position requires the ability to maintain an appropriate work pace; to comprehend and follow instructions; to read, count and compute; to exercise logic and reasoning; to organize and prioritize; to problem solve; to make decisions; to analyze and interpret data; to multi-task/re-direct and experience numerous interruptions.  

    Other Requirements

    Some travel, approximately 15%  

    Work Environment

    The noise level in the work environment is usually quiet to moderate. 

    This job description is not designed to cover an exhaustive list of duties. Other duties may be assigned and activities may change at any time with or without notice.


    Safeguard Medical is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to a work environment that supports, inspires, and respects all individuals and in which personnel processes are merit-based and applied without discrimination based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.


    Safeguard Medical believes that diversity and inclusion among our teammates is critical to our success as a global company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool.



  • 22 Days Ago

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Regulatory Affairs Specialist
  • PSI CRO AG
  • NC, NC FULL_TIME
  • PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on deliveri...
  • 22 Days Ago

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Regulatory Affairs Specialist.
  • PSI
  • Durham, NC FULL_TIME
  • Job Description Join our team of experts in regulatory and ethics submissions of clinical studies! You will focus on facilitating the start of research projects of novel medicinal products, while taki...
  • 23 Days Ago

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Regulatory Affairs Specialist
  • PSI CRO
  • Durham, NC FULL_TIME
  • Company DescriptionPSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. W...
  • 14 Days Ago

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Regulatory Affairs Senior Specialist - Medical Devices
  • Career Opportunities at Merz North America
  • Raleigh, NC FULL_TIME
  • The Regulatory Affairs Senior Specialist - Medical Devices coordinates the regulatory activities for development projects including new products and life cycle management. This includes assisting with...
  • 3 Days Ago

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Principal Regulatory Affairs Specialist (Burts Bees / OTC)
  • US51 Clorox Services Company
  • Durham, NC FULL_TIME
  • Clorox is the place that’s committed to growth – for our people and our brands. Guided by our purpose and values, and with people at the center of everything we do, we believe every one of us can make...
  • 1 Month Ago

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Regulatory Affairs Specialist
  • Sally Beauty Holdings, Inc.
  • Denton, TX
  • Review labels of private label products for regulatory compliance in the US and applicable international markets. Review...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Katalyst Healthcares & Life Sciences
  • Tampa, FL
  • Responsibilities: Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electroni...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • ConvaTec
  • Lexington, MA
  • Product Regulatory Affairs work includes: Directing submission development of product registration, progress reports, su...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Planet Pharma
  • Immediate need for Regulatory Affairs Specialist with a Clinical Research Organization in Raleigh. Hybrid position - wil...
  • 3/27/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Tephra
  • Cincinnati, OH
  • Description: The candidate will work with client & Client teams to deliver best in-class solutions for regulatory submis...
  • 3/27/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Akkodis
  • Irvine, CA
  • Akkodis is seeking an Regulatory Affairs Specialist for a company located in Candidates need to be local to a Irvine ,CA...
  • 3/26/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Tephra
  • Edison, NJ
  • Description: The candidates will work with client & Our client's teams to deliver best in-class solutions for regulatory...
  • 3/26/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • The Judge Group
  • Horsham, PA
  • Regulatory Affairs Specialistreq38824Employment Type: RegularLocation: HORSHAM,PAHave you ever enjoyed Arnold, Brownberr...
  • 3/26/2024 12:00:00 AM

North Carolina (/ˌkærəˈlaɪnə/ (listen)) is a state in the southeastern region of the United States. It borders South Carolina and Georgia to the south, Tennessee to the west, Virginia to the north, and the Atlantic Ocean to the east. North Carolina is the 28th-most extensive and the 9th-most populous of the U.S. states. The state is divided into 100 counties. The capital is Raleigh, which along with Durham and Chapel Hill is home to the largest research park in the United States (Research Triangle Park). The most populous municipality is Charlotte, which is the second-largest banking center in...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$72,671 to $97,389

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