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Title:  Principal, Regulatory Affairs - Device Software (Remote)

Requisition ID:  44186
Date:  Nov 25, 2021
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 Principal is expected to perform with minimal supervision and is responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory approval, preparing global submissions including Premarket Notifications, Global Registrations, Technical Documentation for CE Marking or those associated with NDAs, BLAs, MAAs. The Principal ensures timely and high-quality execution of all regulatory deliverables. In addition, the Principal mentors team members 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 accommodate a remote work location.

 

Essential Duties and Responsibilities:

  • Develop and implement regulatory strategies for medical devices and combination products with an emphasis on gaining regional regulatory approval/clearance/licensure in the most efficient, compliant manner
  • Author and Review complex product submissions and negotiate submission issues with Agency personnel. All significant issues will be reviewed with the manager and/or other senior management
  • Work 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, and international submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release
  • Prepare regulatory strategies/plans and worldwide requirement lists.
  • Provide leadership to product development teams for regulatory issues and questions
  • Provide support to market-released products as necessary. This includes reviewing labeling, promotional material, 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
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes
  • Prepare submissions and reports for FDA and support other major market regulatory agencies as required by product status
  • Read and interpret regulations for new and current compliance procedures and regulatory enforcement trends/actions
  • Develop proficiency in worldwide regulatory requirements and establish and maintain good working relationships with agency personnel
  • 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
  • Clearly and effectively communicate strategy/project progress/status, decisions, timelines, etc. to internal/external stakeholders and RA management
  • Develop specific objectives and manage work assignments, with minimal 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 4-6 years; Master’s degree/PhD 3-4 years Regulatory Affairs experience supporting medical devices and/or drug/combination products.
  • Minimum US Class II and EU Class IIa device experience and in-depth knowledge of US FDA regulations (Title 21) and EU MDD (93/42/EEC) and MDR (2017/745)
  • History of successful EU technical documentation submissions
  • Advanced knowledge of 21 CFR 820/ISO 13485
  • Advanced knowledge of product life cycle, product development process, design control and change control
  • Experience with software-containing devices and medical device capital equipment and IEC 60601-1:2005
  • Experience directly interacting with government agencies
  • Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance). 
  • Experience reviewing product labeling and advertising/promotional material for medical devices
  • Strong negotiation and decision-making skills
  • Excellent oral communication and technical writing skills
  • Self-motivated with a proactive attitude and the ability to work effectively

 

Preferred Knowledge, Skills and Abilities:

  • International regulatory competency
  • Advanced degree 
  • R.A.C certification(s)
  • Experience with delivery systems preferred

 

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 upon 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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