Regulatory Affairs Specialist jobs in Charlotte, NC

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.



  • 21 Days Ago

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Oncology Research Specialist – Regulatory Affairs & Compliance – Credentialing/Delegation - Charlotte - FT
  • Candidate Experience site
  • Charlotte, NC FULL_TIME
  • Job Summary Coordinates clinical, regulatory, business, and other research- related activities and documentation for clinical trials conducted, follows industry standards and applicable regulations in...
  • 19 Days Ago

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Director, Regulatory Affairs
  • Octapharma Plasma, Inc.
  • Charlotte, NC FULL_TIME
  • How to Maximize your opportunity to do rewarding work, your future leadership potential, and your career growth? Join an Industry Leader [Become one, too!] Octapharma Plasma offers professional opport...
  • 19 Days Ago

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Director, Regulatory Affairs
  • Default Board
  • Charlotte, NC FULL_TIME
  • How to Maximizeyour opportunity to do rewarding work,your future leadership potential,and your career growth? Join an Industry Leader[Become one, too!] Octapharma Plasma offers professional opportunit...
  • 18 Days Ago

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Regulatory specialist
  • Volt
  • Charlotte, NC FULL_TIME
  • Volt is immediately hiring a Remote-Regulatory Affairs Specialist , with a well-known industry leader. In this Role you will have the opportunity to participate in a global healthcare spin off and act...
  • 4 Days Ago

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Charlotte, NC FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 11 Days Ago

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0 Regulatory Affairs Specialist jobs found in Charlotte, NC area

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Director, Accounting & Auditing
  • Charlotte-Mecklenburg Schools
  • Charlotte, NC
  • Non Instructional/Support Services Job Number 4600289716 Start Date Open Date 02/28/2024 Closing Date 03/31/2024 Summary...
  • 3/28/2024 12:00:00 AM

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Sr Risk Control Consultant, Field
  • The Travelers Indemnity Company
  • Charlotte, NC
  • Who Are We? Taking care of our customers, our communities and each other. That's the Travelers Promise. By honoring this...
  • 3/28/2024 12:00:00 AM

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AVP, Deposits Risk
  • Synchrony Financial
  • Charlotte, NC
  • Job Description: Role Summary/Purpose: This role will contribute to consumer compliance and operational risk oversight o...
  • 3/27/2024 12:00:00 AM

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Sr. Financial Analyst
  • Founders Federal Credit Union
  • Lancaster, SC
  • Job Description Job Description Relax... Join Our Team! Founders Federal Credit Union helps our members attain their fin...
  • 3/27/2024 12:00:00 AM

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Operational Risk Officer w/ RCSA
  • Experis
  • Charlotte, NC
  • Job Title: RCSA Business Analyst Location: Charlotte, NC and Hudson Yards, NYC Industry: Financial Services Contract Ter...
  • 3/26/2024 12:00:00 AM

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Treasury Data Analyst
  • Insight Global
  • Charlotte, NC
  • Insight Global is looking for a Treasury Analyst to join a data management team at a large financial client in the Uptow...
  • 3/25/2024 12:00:00 AM

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VP/Associate Compliance Governance
  • Phyton Talent Advisors
  • Charlotte, NC
  • We are seeking a Compliance Governance candidate on behalf of our client a reinsurance firm the in Charlotte, NC. This o...
  • 3/24/2024 12:00:00 AM

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Treasury Analyst
  • Insight Global
  • Charlotte, NC
  • Required Skills 3+ years of financial and/or data analytics experience with a financial institution Bachelor’s Degree in...
  • 3/24/2024 12:00:00 AM

Charlotte (/ˈʃɑːrlət/) is the most populous city in the U.S. state of North Carolina. Located in the Piedmont, it is the county seat of Mecklenburg County. In 2017, the U.S. Census Bureau estimated the population was 859,035, making it the 17th-most populous city in the United States. The Charlotte metropolitan area's population ranks 22nd in the U.S., and had a 2016 population of 2,474,314. The Charlotte metropolitan area is part of a sixteen-county market region or combined statistical area with a 2016 census-estimated population of 2,632,249. Between 2004 and 2014, Charlotte was ranked as...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$73,949 to $99,102
Charlotte, North Carolina area prices
were up 1.5% from a year ago

Regulatory Affairs Specialist in Long Beach, CA
In addition to keeping informed of licensing and legal documentation requirements, a regulatory affairs specialist is involved in less-visible yet vastly important industry issues, such as packaging and labeling.
December 16, 2019
Regulatory Affairs Specialist in Albuquerque, NM
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
February 20, 2020
Regulatory Affairs Specialist in Petaluma, CA
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020