Regulatory Affairs Specialist
Job Summary
The Regulatory Affairs Sr. Specialist is responsible for post market activities for medical devices, supporting department regulatory processes and procedures, and authoring global registrations.
Key Responsibilities
* Support regulatory strategies for OUS medical devices and combination products, ensuring compliance with global guidelines and industry standards.
* Author regulatory documentation such as CIAs, Technical Documents, PMS Plans, PSURs, PMCF, and vigilance reports to Notified Bodies, EMA, and other global competent authorities.
* Complete global Post Market Surveillance (PMS) activities and assignments for OUS medical devices and combination products in West's portfolio.
* Support West's medical device EU importation requirements as Importer in accordance with Article 13 of MDR.
* Provide technical review of data and reports supporting regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation are fit for purpose.
* Collaborate with cross-functional teams and external stakeholders to provide guidance, issue resolution, responses to inquiries, and actions taken.
Required Skills and Qualifications
* Bachelor's Degree in science, math, engineering, or related discipline required; Master's Degree or PhD preferred.
* Experience: Bachelors with +5 years or master's degree/PhD with 3+ years of medical device regulatory experience.
* Experience with EU MDD (93/42/EEC), EU MDR (2017/745), MDCG guidance, ISO 13485 and US FDA regulations (Title 21CFR820), ISO 14971, and ISO 14155.
Benefits
* Lifelong learning, growth, and development opportunities.
* Benefit programs that empower physical, mental, emotional, and financial health of team members and their families.
Working Conditions
* Ability to work independently and manage multiple priorities.
* 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.
Keyword: RegulatoryAffairs