West Pharma RA Intelligence Principal - Medical Device 

United States, Pennsylvania, West Whiteland Township 

496534828

Job Summary:

The Principal, Regulatory Affairs, Intelligence, Medical Device is expected to perform with minimal supervision and isan experienced and detail-oriented professional with expertise in medical devices with an understanding of combination products and containment systems. The successful candidate will play a crucial role in ensuring compliance with regulatory requirements for medical devices, including considerations for combination products and containment systems.This role requires a deep understanding of global regulatory frameworks, strong project management skills, and the ability to effectively collaborate with cross-functional teams and external vendors.

Essential Duties and Responsibilities:

• Perform surveillance activities by researching, identifying, and communicating up to date global medical device regulatory requirements that facilitate development, registration, submission and post marketing of West’s products and services. Surveillance areas include, but are not limited to, medical devices, combination products, containment, labeling, packaging, and software.
• Research and articulate the latest regulatory intelligence to internal stakeholders and contextualize the impact on West portfolio and business. Ensure that changes to applicable regulations are clearly and effectively communicated to drive action.
• Develop intelligence of emerging regulatory trends and communicate implications to internal stakeholders and external customers through updates to relevant portions of Master Regulatory Plan(s), trainings, presentations, white papers, etc.
• Monitor, analyze, and recommend action plans for current and future industry initiatives anddraft public comments in response to regulations and guidance issued by regulators and health authorities.
• Collaborate with R&D, Quality Assurance, Clinical Affairs, and other departments to ensure alignment with regulatory requirements including but not limited to participating in project teams to provide regulatory guidance throughout the product lifecycle.
• Collaborate with and lead discussions with consultants and external vendors to assist in global regulatory strategies. Participate in industry events, conferences, or working groups, as applicable.
• Manage relationships, including subscriptions, with regulatory vendors, ensuring timely delivery of documentation and materials.
• Provide training to internal teams on regulatory requirements and updates related to medical devices and combination products.
• Maintain a high level of regulatory awareness through buildinginfluence through engagement in relevant trade associations, coalitions, and alliances.
• Other duties as assigned.

Basic Qualifications:

• Education: Bachelor’s, Master’s degree or PhD in science, math, engineering or related discipline
• Experience: Minimum 8 years.
• Able to work collaboratively across all levels of the organization to influence and persuade others.
• Experience directly interacting and presenting to project teams, customers, industry groups
• Demonstrated understanding of related medical device and containment operations (e.g. manufacturing process development, analytical, quality systems)
• Strong negotiation and decision-making skills.
• Excellent written and verbal communication, timeline management and leadership skill
• Self-motivated with a proactive attitude and the ability to work effectively.
• Ability to work collaboratively in a cross-functional team environment.
• Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.

Preferred Knowledge, Skills and Abilities:

• Regulatory compliance competency including ISO 13485 certified Quality Systems
• International regulatory competency
• Advanced degree
• Regulatory Affairs Certification (R.A.C)
• 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 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.