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Title:  Regulatory Affairs Specialist - Medical Devices (Remote)

Requisition ID:  48961
Date:  Jun 11, 2022
Location: 

Exton, Pennsylvania, US

Department:  Regulatory Affairs
Description: 

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:

The Regulatory Affairs Specialist is expected to perform with input from management and is responsible for coordinating and authoring regulatory submissions, including Premarket Notifications, Global Registrations, Technical Documentation for CE Marking or those associated with NDAs, BLAs, MAAs.   The Specialist ensures timely and quality execution of all regulatory deliverables.  In addition, the specialist collaborates with team members, to provide support for global regulatory approvals (beyond US and EU), commercialized products, and ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This position includes supporting internal and external customer regulatory requests. This position can accomodate a remote work location.

 

Essential Duties and Responsibilities:

  • Complete structured regulatory assignments with management input for administration and safety systems with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in the most efficient, compliant manner
  • Author global submissions with guidance, with significant issues to be reviewed with regulatory management
  • Review assigned technical project documentation, certifications, correspondences, and external communications as needed
  • Collaborate with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams to ensure submissions are accurately prepared and comply with global regulations
  • Prepare US, EU, China and other international submissions as applicable for existing and new products and product changes as required to ensure timely approvals for market release
  • Provide support to market-released products as necessary. This includes reviewing product/manufacturing process changes and documentation for changes requiring regulatory approval
  • Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation
  • Work with management to determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes
  • Read and interpret regulations for new and current compliance procedures and regulatory enforcement trends/actions
  • Gain knowledge in worldwide regulatory requirements
  • Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products
  • Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.
  • Write or update standard operating procedures, work instructions, or policies with guidance
  • Clearly and effectively communicate team/project progress/status, decisions, timelines, issues etc. to RA management
  • Develop specific objectives and manage work assignments, with guidance to achieve personal objectives in conformance with overall business goals
  • Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures
  • Challenge processes, remain open to ideas and changes to continuously improve, seek better alternatives, and drive change
  • Adhere to all applicable government and West regulations, practices, and procedures to maintain compliance
  • Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as required
  • Other duties as assigned

 

Basic Qualifications: 

  • Education:  Bachelor’s, Master’s degree or PhD in science, math, engineering or related discipline
  • Experience:   Bachelor’s with 2-4 years; Master’s degree/PhD 1-2 years medical device regulatory experience
  • Knowledge of 21 CFR 820/ISO 13485
  • Attention to detail and strong decision-making skills
  • Good oral communication and technical writing skills
  • Self-motivated with a proactive attitude and the ability to work effectively

 

Preferred Knowledge, Skills and Abilities:

  • Knowledge of product life cycle, product development process, design control and change control
  • Demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance). 
  • Regulatory compliance competency including Quality Systems
  • International regulatory competency
  • R.A.C certification(s)
  • Experience with administration and safety systems preferred
  • Ability to discriminate between critical and non-critical activities and to follow established processes while identifying areas for process improvement
  • Attention to detail with planning, time management and organizational skills

 

Travel Requirements:

  • Must be able to travel up to 5 – 10 % of the time

 

Physical & Mental Requirements:

Ability to comprehend principles of math, science, engineering, and medical device use.  Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality. Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents. Ability to review, collate, describe, and summarize scientific and technical data. Ability to organize complex information and combine pieces of information to form general rules or conclusions.  Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one. Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments. Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams. Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures. Ability to build strong relationships both internally and externally. Ability to work in a fast-paced environment.

 

Ability to comprehend and apply language skills to the degree required to perform the job based on the job requirements listed above.  Ability to verbally communicate ideas and issues effectively to other team members and management.  Ability to write and record data and information as required by procedures.

 

Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).

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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