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Sr. Specialist Regulatory Affairs, MD
Sr. Specialist Regulatory Affairs, MDWest Pharmaceutical Services • Exton, PA, US
Sr. Specialist Regulatory Affairs, MD

Sr. Specialist Regulatory Affairs, MD

West Pharmaceutical Services • Exton, PA, US
13 hours ago
Job type
  • Full-time
Job description

Sr. Specialist Regulatory Affairs, MD

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. No relocation is provided for this opportunity.

Who We Are :

At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary

The Regulatory Affairs Sr. Specialist is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, Post Market Submissions, China NMPA Registrations, Technical Documentation for CE Marking, technical packages. The Sr. Specialist ensures timely and high-quality execution of all regulatory deliverables. In addition, the Sr. Specialist mentors team members and ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This position includes supporting internal and external customer regulatory requests.

Essential Duties and Responsibilities

  • Develop and implement medical device regulatory strategies for Wests 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, Japan, 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
  • Create documentation in response to customer regulatory requests which include regulatory letters, technical packages, etc.
  • 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

  • Education : Bachelors, Masters degree or PhD in science, math, engineering, or related discipline
  • Experience : Bachelors with 5+ years; Masters degree / PhD with 3+ years of medical device, pharmaceutical or regulatory experience

    • Work Experience

  • Bachelors with 5+ years of medical device, pharmaceutical or regulatory experience
  • Masters degree / PhD with 3+ years of medical device, pharmaceutical or regulatory experience

    • Preferred Knowledge, Skills and Abilities

  • Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
  • Able to comply with the companys safety and quality policy at all times
  • International regulatory competency
  • 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

    • License and Certifications

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

    • Travel Requirements

    10% : Up to 26 business days per year

    Physical Requirements

    Sedentary-Exerting up to 10lbs / 4kgs of force occasionally, and / or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

    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.
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    Regulatory Specialist • Exton, PA, US