Hiring: Principal Specialist, Regulatory Affairs Company: West Pharmaceutical Services Location: Scottsdale, AZ Job Posted Time: 2026-09-10 14:02:08 Employment Type: Hybrid Target Skills & Keywords : Microsoft Excel, Microsoft PowerPoint, Quality Assurance About the job Experience: •Minimum 8 years related work experience required. •Medical device or Combination Product regulatory experience preferred. Required Skills: •This is a hybrid position requiring the team member to be onsite for a minimum of 3 days per week •No relocation is provided for this opportunity •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. •Develop and implement medical device regulatory strategies for administration and safety systems with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in the most efficient, compliant manner. •Author and review complex product submissions guidance and negotiate submission issues with Agency personnel. •Interface directly with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams to ensure submissions are accurately prepared and comply with global regulations. •Prepare US, EU, and other international submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release. Qualifications: •Bachelor's Degree science, math, engineering, life sciences or related discipline required. •Excellent oral communication and technical writing skills •Advanced knowledge of product life cycle, product development, design control and change control. •Minimum US Class I and EU Class IIa device experience and in-depth knowledge of US FDA regulations (Title 21CFR820) and EU MDD (93/42/EEC) and MDR (2017/745) •History of successful US 510(k) device and EU technical documentation submissions. •Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance). •Strong negotiation and decision-making skills. •Self-motivated with a proactive attitude and the ability to work effectively. •Demonstrated capacity to manage multiple priorities. •RAPS Regulatory Affairs Certifications (RAC)-Medical Devices - Upon Hire preferred Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!