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Regulatory Affairs Specialist (Remote)

 

Description

Phillips-Medisize a Molex Company is looking for a Regulatory Affairs Specialist to support the divisional regulatory affairs system with special focus on Regulatory intelligence and development/maintenance of compliance with new requirements as they are released.

What You Will Do In Your Role

  • Provide regulatory support for early-stage projects, up to the point where a local regulatory project team member is assigned.
  • Regulatory support for project teams and customers for facility licensing activities.
  • Review change controls related to proposed products and or process changes and their impact on current site certificates/registrations.
  • Manage the regulatory intelligence process to ensure that project teams are aware of changes that impact projects, and that current systems in-place are updated to comply with the changes in regulations and standards
  • Collecting submission feedback and using the information to improve the Regulatory documents and templates in use.
  • Update and maintain regulatory information management systems.
  • Complete product safety screening reports.
  • Ensure all product quality standards and specifications are defined and achieved in line with company and Regulatory requirements 
  • After initial development maintain standard templates for customer agreements where we have some regulatory responsibility for the product.
  • Manage standard management system for MPS.
  • Lead knowledge and process development of the divisional regulatory system.
  • Support understand of Notified body and regulatory authorities processes and guiding sites on requirements.
  • Carry out and attend audits (internal + external) including post processing and support of improvement actions.
  • Support to maintain and improve of the Quality Management System in alignment of defined norms / regulatory affairs, including the customer requirements.
  • You will continue to develop and maintain your current regulatory knowledge and be part of the team that does regulatory training for other departments.

The Experience You Will Bring

Requirements:

  • A degree in the science of engineering
  • Proven experience in medical device industry in a Quality or Regulatory Affairs role.
  • Working knowledge of FDA requirements including Quality System Regulation (21 CFR 820), the EU MDD/MDR and applicable harmonized standards and the ability to apply them in practice.
  • Previous experience with submissions to US FDA.

What Will Put You Ahead

  • Proficiency in use of MS office.
  • Technical report writing skills.
  • Demonstrated attention to detail.
  • Ability to work independently or in a team environment.
  • Excellent English (both written and verbal).


Our goal is for each employee, and their families, to live fulfilling and healthy lives. We provide essential resources and support to build and maintain physical, financial, and emotional strength - focusing on overall wellbeing so you can focus on what matters most. Our benefits plan includes - medical, dental, vision, flexible spending and health savings accounts, life insurance, ADD, disability, retirement, paid vacation/time off, educational assistance, and may also include infertility assistance, paid parental leave and adoption assistance. Specific eligibility criteria is set by the applicable Summary Plan Description, policy or guideline and benefits may vary by geographic region. If you have questions on what benefits apply to you, please speak to your recruiter.


At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate’s knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.


For this role, we anticipate paying $ 61,000 - $ 107,000 per year. This role is eligible for variable pay, issued as a monetary bonus or in another form. 


Equal Opportunity Employer.
Except where prohibited by state law, all offers of employment are conditioned upon successfully passing a drug test. 
This employer uses E-Verify.  Please visit the following website for additional information: www.kochcareers.com/doc/Everify.pdf

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