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Title:  Senior Specialist, Regulatory Affairs, Medical Devices (Remote)

Requisition ID:  44282
Date:  Jan 2, 2022
Location: 

Remote, Remote, 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 Sr. Specialist is responsible for influencing department regulatory processes and procedures, developing strategies for worldwide labeling and change control coordination for Administration and Safety System medical devices.  Responsible for leading projects in support of product labeling activities throughout various stages of design and development of delivery systems and combination products.  Maintain knowledge of current FDA, EMA and international regulations/guidelines/policies related to medical devices as applicable to West’s products and services. This position can accommodate a remote work location.

 

Essential Duties and Responsibilities:

  • Accountable for initial creation and control process for labeling of administration and safety systems in the form of development and maintenance of labeling proofs, associated labeling documents, maintain labeling issuance and tracking systems, and provide status updates to management change requests and notification to stakeholders, ensuring documents are produced in a timely manner in accordance with West procedures and regulatory requirements
  • Initiate and Support change control processes for global product registration, submission and post marketing of Administration and Safety System medical devices in West’s portfolio
  • Create, guide, and advise on internal labeling guidance and policies, including product labels, Unique Device Identification (UDI), Instructions for Use (IFUs) and promotional materials
  • Lead meetings with cross-functional teams to review and approve labeling proof documents ensuring completeness and accuracy in accordance with regulatory and marketing requirements
  • Provide strategic input to internal partners and manage feedback from stakeholders on labeling requirements and issue resolution
  • Monitor, interpret and communicate existing and new regulatory requirements related to labeling for delivery system and combination product portfolio
  • Determine translations requirements to develop and maintain a translation process required for global labeling
  • Collaborate with RA submission teams to support timely and quality regulatory submissions and approvals globally
  • Contribute and support continuous improvements to the end-to-end labeling and change control processes including policies, procedures, quality, and system tools
  • Assist Regulatory Policy and Intelligence team where necessary in the review of promotional materials as they relate labeling for delivery systems
  • Work with cross functional RA team to build regulatory strategies and worldwide requirements for labeling other product lines
  • Advise and guide internal and external customers on regulatory strategies, regional regulatory risks that may impact the business as applicable to labeling
  • Develop specific objectives and manage work assignments, with minimal guidance to achieve labeling objectives in conformance with global regulatory and business goals
  • Mentor and support RA staff and peers to achieve personal, departmental, and corporate objectives
  • Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures
  • Maintain working knowledge of computer software packages including MS Word, MS Excel, MS PowerPoint, Master Control, Adobe, SharePoint, MS Teams, Outlook, 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 3-5 years; Master’s degree/PhD 2-3 years medical device, pharmaceutical or regulatory experience
  • 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)
  • Advanced knowledge of 21 CFR 803 and 820/ISO 13485
  • Ability to work effectively in multinational/multicultural environment
  • Ability to manage complex projects and timelines in a matrix team environment
  • Strong interpersonal, communication, negotiation, and presentation skills
  • Ability to mentor and guide others
  • Ability to independently identify compliance risks and escalate when necessary

Preferred Knowledge, Skills and Abilities:

  • Regulatory compliance competency including Quality Systems
  • International regulatory competency
  • Advanced degree 
  • R.A.C certification(s)
  • Experience with administration and drug delivery systems preferred

 

Travel Requirements:

  • Must be able to travel up to 5 – 10 % of the time (meeting, trainings, projects, industry events)

 

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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