Senior Specialist, Regulatory Affairs, Medical Devices

Essential Duties and Responsibilities

• Develop and implement medical device regulatory strategies for West's Transfer Devices with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant manner.
• Author and review US, EU, South Korea, China and additional international submissions with guidance for new products, product changes and post-market updates as required to ensure timely approvals for market release and file maintenance.
• Works with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams to ensure submissions are accurately prepared and comply with global regulations.
• Provide leadership to product development teams for regulatory issues and questions.
• Provide support to market-released products as necessary, including reviewing labeling, promotional material, product/manufacturing process changes, post-market reporting and documentation.
• Establish and maintain good working relationships with agency personnel.
• Compile and maintain regulatory databases or systems as well as technical documentation required for new or modified products.
• Write or update standard operating procedures, work instructions, or policies.
• Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to RA management, internal and external customers.
• 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.
• Other duties as assigned.

Education

Bachelor's or Master's degree or PhD in science, math, engineering, or related discipline or equivalent experience.

Work Experience

Bachelor's with minimum 5 years; Master's degree/PhD with minimum 3 years of medical device, pharmaceutical or regulatory experience.

Preferred Knowledge, Skills and Abilities

• International regulatory competency.
• Attention to detail with planning, time management and organizational skills.
• Knowledge of 21 CFR 820/ISO 13485.
• Possesses technical leadership skills, as well as demonstrated understanding of related medical device and pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).
• 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.
• Experience directly interacting and presenting to project teams and customers.
• Strong negotiation and decision-making skills.
• Excellent written and verbal communication, timeline management skill.
• Self-motivated with a proactive attitude and the ability to work effectively.
• Regulatory compliance competency including Quality Systems.
• R.A.C certification(s).

License and Certifications

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

Travel Requirements

10%: Up to 26 business days per year.

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.