Title:  Sr. Specialist, Post Marketing Surveillance

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary:

In this role, you will be responsible for regulatory review of post-market changes to marketed medical devices that are part of drug / device combination products in the West drug delivery portfolio.  The Sr. Specialist will provide regulatory guidance to change control review boards and will support sustaining engineering teams as assigned concerning regulatory requirements for notification, submission, and compliant implementation of proposed changes to products and processes.  The Sr. Specialist will also be responsible for maintaining annual updates to associated global regulatory filings.  Additionally, the Sr. Specialist will compile and submit reportable events to relevant regulatory authorities in timely manner and assist in handling recalls and field actions, if required.

 This position includes supporting internal and external customer regulatory requests.

Essential Duties and Responsibilities:

• Prepare US, EU and international submissions for product changes as required to ensure timely approvals for clinical studies and market release
• Author and review complex product submissions with guidance and negotiate submission issues with regulatory agency personnel
• Provides review of complaint to ensure all information needed for reporting MDRs / Vigilance is present; determine if further investigation is needed and track investigation to conclusion.
  • Writes MDR / Vigilance reports and submits to the necessary authorities
  • Monitors and improves tracking/control systems for medical device reporting
  • Investigates and prepares responses to address Competent Authority inquiries and provide follow‐up
• 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 and documentation for changes requiring regulatory approval
• Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation
• Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed product or labeling changes
• Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.
• Write or update standard operating procedures, work instructions, or policies
• Other duties as assigned

Basic Qualifications: 

• Minimum Bachelor’s degree required
• Minimum 5 years’ experience in medical device / combination product regulatory affairs

Preferred Knowledge, Skills and Abilities:

• Knowledge of drug / device combination product global regulations and guidance’s
•  Demonstrates success in supporting product and process changes, including complex projects involving ambiguity and rapid change.
• Ability to analyze complex issues and to formulate cogent approaches to resolving/addressing issues.
• Ability to create and analyze post-market activity metrics to facilitate functional strategic planning and resourcing associated with post-market product and process changes due to either internal or external drivers.
• Ability to handle multiple tasks, organize and prioritize work, maintain schedules, and provide updates to managers and cross-functional collaborators.
• Knowledge of regulations applying to medical devices and in vitro diagnostic devices in the U.S., EU and other jurisdictions, as appropriate.
• Must be a self-starter, detail-oriented and confident decision maker
• Able to comply with the company’s safety policy at all times

Travel Requirements:

• Must be able to travel up to 10% of the time

Physical and Mental Requirements:

• Ability to work in sedentary environment, in an office; may need to stand or sit for extended periods of time

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.