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RA Specialist Temp

Requisition ID:  34926
Date:  Apr 8, 2021
Location: 

Ra'anana, Central district, IL

Department:  Regulatory Affairs

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Job Summary:

In this role, you will be assisting RA activities WW for all administration system devices and

responsible for supporting RA global for any related activities.

 

Essential Duties and Responsibilities:

 

  • Maintain Post Marketing activities (PMS, CER, PMCF, PSUR)
  • Responsible EUDAMED responsibilities (DoC per batch record, public information review)
  • Assist regulatory assignments independently in support of R&D and commercial programs with a focus on authoring, maintenance for submission to Health Authorities [DMFs, MAFs, 510(k)s], customer requests, etc.] in compliance with regulations, guidelines and procedures.
  • Provide regulatory expertise and operational direction to internal, and external customers to ensure conformance and compliance with corporate requirements, government regulations, guidelines and industry standards.
  • Work closely with RA department to successfully achieve cross functional departmental objectives.
  • Provide regulatory representation on project steering teams, as necessary.
  • Review technical project documentation, certifications, correspondences, and external communications, as needed, providing guidance and direction where applicable.
  • Adhere to all applicable government and West regulations, practices and procedures to maintain compliance.
  • Evaluation of a complaint to MDR / Vigilance: approval of the evaluation of a complaint after its implementation by the person responsible for complaints of quality assurance.
  • Labeling review
  • Working with WEST internal/external representative
  • Other duties as assigned

 

 

Basic Qualifications: 

  • Education: Bachelor’s or master’s related discipline.
  • Experience: Bachelor’s or master’s degree with 1-3 years’ experience in regulatory/pharmaceutical experience.  

Preferred Knowledge, languages, Skills and Abilities:

  • Strong technical skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).
  • Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required.
  • Excellent interpersonal, communication and listening skills with a proven record of working with and influencing multi-disciplinary teams and external experts.
  • Experience in Regulatory Affairs projects

 

Travel Requirements:

  • N/A

 

 

Competencies/Authorities

 

  • Labelling Review, IFU and all commercial documentation/site, per relevant regulatory requirements
  • Working with EU representative/Virtual manufacturer/ other representatives in the world
  • Evaluation of a complaint to MDR / Vigilance: evaluation of a complaint after its implementation by the person responsible for complaints of quality assurance.
  • Approval every DoC per Lot.

 

Delegation/s (Title): RA Specialist

 

 

 

 

 

 

 

 

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to kimberley.eby@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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