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Title:  SR. RA Specialist

Requisition ID:  65651
Date:  Oct 28, 2024
Location: 

Ra'anana, Central district, IL

Department:  Legal
Description: 

 

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  

 

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

 

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

Job Summary:

The Regulatory Affairs Sr. Specialist is expected to perform with minimal support and is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, China NMPA Registrations, Technical Documentation for CE Marking and technical packages. The Sr. Specialist ensures timely and high-quality execution of all regulatory deliverables. In addition, the Sr. Specialist mentors team members and ensures compliance with West Pharmaceutical Services, Inc. (West) and applicable regulatory requirements. This position includes supporting internal and external customer regulatory requests.

 

Essential Duties and Responsibilities:

  1. Develop and implement medical device regulatory strategies for West’s Administration and Safety Systems portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant manner
  2. Author and review US, EU, Japan, China, and additional international submissions with guidance for new products and product changes as required to ensure timely approvals for market release
  3. Work with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams to ensure submissions are accurately prepared and comply with global regulations
  4. Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation
  5. Provide support to market-released products as necessary, including reviewing manufacturing process changes and documentation for changes requiring regulatory approval
  6. Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products
  7. Create documentation in response to customer and regulatory agency requests, including regulatory letters, technical packages, etc.
  8. Write or update standard operating procedures, work instructions, or policies
  9. Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures
  10. Challenge processes, remain open to ideas and changes to continuously improve, seek better alternatives, and drive change
  11. Adhere to all applicable government and West regulations, practices, and procedures to maintain compliance

Basic Qualifications: 

 

Bachelor's Degree- in science, math, engineering, or related discipline- required

Master's Degree- in science, math, engineering, or related discipline- an advantage

PhD- in science, math, engineering, or related discipline- an advantage

Preferred Knowledge, languages, Skills and Abilities:

  • Bilingual -  English and Hebrew
  • Advanced knowledge of 21 CFR 820/ISO 13485
  • Advanced knowledge of product life cycle, product development process, design control and change control and 21 CFR 820/ISO 13485
  • Possesses technical leadership skills, as well as demonstrated understanding of related medical device operations (e.g., Design History File (DHF) maintenance, manufacturing, process development, analytical, quality assurance).
  • Excellent oral communication, technical writing, and decision-making skills
  • Self-motivated with a proactive attitude and the ability to work effectively
  • Regulatory compliance and International competency including Quality Systems
  • Ability to discriminate between critical and non-critical activities and to follow established processes while identifying areas for process improvement
  • Excellent oral communication and technical writing skills

Travel Requirements:

  1. Must be able to travel up to 10% of the time.

Physical & Mental Requirements:

 

  1. Very Heavy/ Heavy/ Medium/ Light/ Sedentary: Sedentary
  2. List any mental requirements:
    1. Working under constant pressure to deliver
    2. Ability to work independently and in a cross-functional team.
    3. Good communication skills
    4. Excellent verbal and written communication skills in English.
    5. Technical abilities 

 

 

 

 

 

 

 

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 Apply.Accommodation@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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