Title:  Sr. RA Specialist

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.

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.
• Manage change controls, receiving input from Regulatory SMEs on impact in regions product is registered.
• Apply comprehensive strategic and knowledge, skills/abilities and understanding of the regulatory frameworks, regulatory requirements.
• Accountable for strategic and tactical guidance to product labeling review teams regarding development and maintenance of labeling and associated documents.
• Determine translations requirements to develop and maintain a translation process required for global labeling.
• Other duties as assigned.

Education

• Education- B.sc master’s degree or PhD in science, math, engineering or equivalent

Work Experience

• Experience- Bachelor’s with minimum 5 years or Master’s degree/PhD 2-3 years of medical device, pharmaceutical or regulatory experience

Preferred Knowledge, Skills and Abilities

• Fluent in English
• 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
• Possesses technical leadership skills, as well as demonstrated understanding with product labeling, advertising and promotional materials for medical devices
• Ability to work effectively in multinational/multicultural environment
• Self-motivated with a proactive attitude and the ability to work effectively
• Regulatory compliance competency including Quality 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

License and Certifications

• Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred

Travel Requirements

Physical Requirements

Additional 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).