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Title:  Principal, Regulatory Affairs - Post-Market Surveillance (Remote)

Requisition ID:  55406
Date:  Sep 22, 2022
Location: 

Exton, Pennsylvania, US

Department:  Regulatory Affairs
Description: 

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:

The Regulatory Affairs Principal is responsible for post market activities for Administration and Safety System medical devices.  The Principal will influence department regulatory processes and procedures, supporting strategies for worldwide PMS activities.  Responsible for leading projects in support of product Post Market activities, Adverse Event Reporting, and device risk management throughout various stages of design and development of Administration and Safety Systems.  Maintain knowledge of current FDA, EMA and international regulations/guidelines/policies related to medical devices as applicable to West’s products and services. This position can accommodate a remote work location.

 

Essential Duties and Responsibilities:

  • Accountable for Post Market Activities for Administration and Safety System medical devices in West’s portfolio.
  • Support establishment and maintenance of procedures, work instructions, and templates associated with Post Market activities.
  • Execute post-market surveillance plans in the commercial lifecycle including periodic review and reporting requirements.
  • Collaborate with cross-functional team members in collecting, analyzing, trending, and reporting on safety and performance data to identify potential adverse safety risks or performance trends.
  • Responsible for complaint monitoring and adverse event reporting. Ensure support of appropriate post market surveillance related submissions and reports to health authorities worldwide in accordance with local procedures.
  • Lead and support the creation and streamline of processes to assure proactive surveillance (database searches, literature reviews) and reactive surveillance (complaints handling, field actions) is conducted efficiently.
  • Lead the generation of Post Market Clinical Follow-up Reports (PMCFR), Clinical Evaluation Report (CER), China NMPA Periodic Risk Evaluation Reports (PRER) and related reports along with supporting the maintenance of appropriate Design History File (DHF) documents and Risk Management Files (RMF).
  • Review promotional materials to assure risk information is included per regulatory requirements.
  • Collaborate with RA submission teams to support timely and quality regulatory submissions and approvals globally.
  • Assist Regulatory Policy and Intelligence team where necessary in the review of promotional materials
  • Develop specific objectives and manage work assignments, with minimal guidance to achieve objectives in conformance with global regulatory and business goals.
  • Mentor and guide RA staff and peers to achieve personal, departmental, and corporate objectives
  • Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures
  • 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
  • Other duties as assigned

 

Basic Qualifications: 

  • Education:  Bachelor’s, Master’s degree or equivalent experience in medical science, nursing or related discipline
  • Experience:   Bachelor’s with 8+ years; Master’s degree 3-4 years medical device, pharmaceutical or regulatory experience

 

Preferred Knowledge, Skills and Abilities:

  • 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 803/820, ISO 13485 and ISO 14971
  • Advanced knowledge of global device adverse event reporting requirements
  • Ability to work effectively in multinational/multicultural environment
  • Ability to manage complex projects and timelines in a matrix team environment
  • Strong interpersonal, communication, negotiation, and presentation skills
  • Ability to lead and coach others
  • Ability to independently identify compliance risks and escalate when necessary
  • International regulatory competency
  • Experience with China NMPA Periodic Risk Evaluation Reports (PRER) is a plus
  • Advanced degree 
  • R.A.C certification(s)
  • Experience with administration and drug delivery systems preferred
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
  • Able to comply with the company’s safety and quality policy at all times

 

Travel Requirements:

  • Must be able to travel up to 5 – 10 % of the time (meeting, trainings, projects, industry events)

 

Physical & Mental Requirements:

  • Ability to work in an office. May need to stand or sit for extended periods of time
  • Ability to research, read, analyze, and interpret regulatory and clinical 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
  • Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures
  • Ability to build strong relationships both internally and externally. Ability to work in a fast-paced environment
  • 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 in English effectively to other team members and management
  • Ability to write and record data and information as required by procedures
  • Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company)

 

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.

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