We are looking for a Sr. RA Specialist.
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 Wests 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.
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 Wests 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.
Requirements:
Education- B.sc masters degree or PhD in science, math, engineering or equivalent
Work Experience:
Experience- Bachelors with minimum 5 years or Masters 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
Education- B.sc masters degree or PhD in science, math, engineering or equivalent
Work Experience:
Experience- Bachelors with minimum 5 years or Masters 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
This position is open to all candidates.
