Regulatory Affairs Specialist

2 weeks ago

Raleigh, United States Connexion Systems & Engineering, Inc. Full time
Job DescriptionJob Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services while treating candidates with the professionalism and respect they deserve.

Job Title: Regulatory Affairs Specialist 3

Notes:

  • Looking for qualified candidates at the Level 3 requirements listed below
  • 100% Remote, prefer EST time zone, must be able to work 8am - 5pm EST
  • No Travel required at this time, that could change but it would be minimal
  • At least 5 years of regulatory experience
  • Won’t be a management role, will be actively working this role, this is less strategy and more of an individual contributor to be very hands on
  • Top must haves
  • Verbal and written skills
  • Some sort of leadership abilities, without being in leadership role is helpful
  • Bachelors (engineering most beneficial but any degree is fine
  • Written several 510k experience is required (must have submitted at least more than 1)
  • Ideally have experience with device that is implantable and device with software
  • Ideally have eSTAR experience
  • Certification is nice to have but not required
  • Interview process: virtual, 2 rounds

Essential Duties and Responsibilities:
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

  • Responsible for the preparation and compiling of document packages for regulatory submissions, audits and inspections. Participates in technical review of data or reports that will be incorporated. Manage and maintain regulatory databases and technical files.
  • Participate in internal and external audits and investigations.
  • Reviews materials such as labeling, marketing materials or user manuals to ensure compliance with regulatory agency requirements and laws.
  • Manage labeling and unique device identification requirements. Recommends changes for labeling, manufacturing, marketing and clinical protocols for regulatory compliance.
  • Provides high-level regulatory support on projects and cross functional teams. Provides technical guidance on design reviews and regulatory strategies for product approval.
  • Contribute to developing or improving processes, procedures and standards that contribute to meeting internal SOP’s, regulatory and industry regulations.
  • Maintains current knowledge of existing and emerging regulations, standards and laws.
  • Administrative Responsibilities include attending all meetings (staff, core team, key one-on-one, multifunctional priority setting meetings, sustaining, etc.), reviewing and responding to emails and other messaging platforms.

Qualifications (Education & Experience):

  • Bachelor's Degree (Engineering, Biomedical or related field preferred), May have Master’s Degree, May have PhD
  • 5-8 Years, Higher education may compensate for years of experience.

Required Skills:

  • Excellent communication, including verbal, technical writing, interpersonal and presentation skills.
  • Proficient with technology applications such as MS Office,
  • Experience with the creation of technical files and documentation
  • Experience working in regulated medical device industry.
  • Knowledge of ISO 13485, ISO 14971, ISO 9001, FDA and foreign regulatory requirements
  • Strong data and statistical analysis skills and ability to use data to make informed recommendations
  • High degree of attention to detail

Beneficial Skills:

  • Regulatory Affairs Certification (RAC)
  • Project Management Experience
  • FDA ESTAR experience
  • Ability to appropriately assess written product and project documentation as the principal advocate for compliance, and ability to effectively communicate assessment
Company DescriptionConnexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.Company DescriptionConnexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.

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