Regulatory Affairs Specialist II

14 May, 2022

Jobs

Regulatory Affairs Specialist II

Smith+Nephew
Austin, TX/Mansfield, MA/Andover, MA/Fort Worth, TX/Memphis, TN

Role Overview:

The Regulatory Affairs Specialist II is responsible for supporting the development and implementation of the overall objectives and regulatory strategies that impact the introduction of new products, sustaining support and the market status of existing products with focus on China and key market submissions.

 

The Regulatory Affairs Specialist II will provide product support activities and processes as required to assure that products manufactured and/or distributed by Smith & Nephew Inc. are in full compliance with U.S. and all applicable global regulatory requirements.

 

**This position does NOT provide visa sponsorship**

 

Responsibilities:

  • Prepares international dossiers for APAC (China) and other key market affiliates, to obtain and maintain global regulatory approvals of products.
  • Generates regulatory strategies for new and modified products, product support on change notifications and quality plans.
  • Interacts with global regulatory agencies to obtain CFG, LoA, etc. as required for product registration. Provides regulatory support for global regulatory teams on international regulatory requirements.
  • Provide customer service necessary regulatory / registration information for compliance and customer requests.
  • Support manufacturing changes for compliance with applicable regulations, including EU MDR and international.
  • Update company databases with required information and statuses for licenses, registrations, renewals, products, and other required data, ie GUID, DI, EUDAMED, RIMSYS etc.
  • Update and maintain knowledge of current developments and changes to applicable laws, regulations and industry standards.
  • Support development of company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements.
  • Provide support for internal and Regulatory Agency audits
  • Build Quality into all aspects of job performance by maintaining compliance to all quality requirements.
  •  Participates in training and development activities as required and other duties as assigned.

 

Location:

  • US – Austin, TX
  • US – Fort Worth, TX
  • US – Andover, MA
  • US – Mansfield, MA
  • US – Memphis, TN

 

Education:

  • Bachelor’s degree preferably in a scientific or technical discipline

 

Licenses/Certification:

  • RAC a plus

 

Experience:

  • 2+ year(s) Regulatory Affairs experience in medical device industry

 

Competencies:

  • Read, understand, and apply global regulations
  • Technical knowledge of medical products
  • Understanding of relevant procedures, practices, and associated medical terminology
  • Knowledge of product development process and design control
  • Excellent research and analytical skills; detail oriented
  • Ability to manage multiple projects
  • Ability to work and problem solve both independently and within a team.
  • Ability to work within deadlines as imposed by government regulations and internal guidelines.
  • Excellent written and oral communication.
  • Prior experience with Product Lifecycle Management Systems and large-scale document management systems a plus
  • Proficiency with SAP, Microsoft Office, Adobe

 

Physical Demands:

  • Requires sitting, talking or listening, more than 2/3 of the time.
  • Walking or standing less than 1/3 of the time.
  • Use of Hands to use computer or write documents less than 2/3 of the time.
  • Ability to travel by air or motor vehicle both domestically and internationally required.  Some overnight travel required.
  • Searching for, lifting and carrying records weighing up to 25 points less than 1/3 of the time.
  • Close vision (clear at 20 inches or less) required to review documents and operate personal computers more than 2/3 of the time.
  • Occasional use of Personal Protective Equipment (PPE) required

 

Travel:

  • 5-15% (Domestic and/or International)

 

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Learn more here

 

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

Job posted: 2022-05-14