Principal Specialist, Regulatory Affairs job at reputed company Pharmaceutical Services in Exton, PA

Title: Principal Specialist, Regulatory Affairs Location: Exton United States Department: Regulatory Affairs Job Description: 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 reputed company, 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 reputed company Herman O. reputed company 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, reputed company'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 reputed company reputed company to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we reputed company the physical, mental, emotional and financial health of reputed company members and their families. We reputed company 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 reputed company through our sustainability efforts. reputed company Offer Generous Paid Time Off (PTO): Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work-life balance and reputed company effectively. Global Career Opportunities: With facilities across North America, Europe, and Asia-Pacific, employees have opportunities for international exposure and cross-functional collaboration. Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion-where reputed company voices are heard and respected in a supportive environment. Recognition & Rewards: Performance-based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact. Job Summary The Principal Specialist, Regulatory Affairs (Medical Devices) is responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory approval, preparing global submissions including Premarket Notifications, Global Registrations, Technical Documentation for CE Marking, and Health Canada submissions. The Principal Specialist ensures timely and high-quality execution of reputed company regulatory deliverables. In addition, the Principal Specialist mentors team members, and provides support for global regulatory approvals (beyond US and EU), commercialized products, and ensures compliance with reputed company Pharmaceutical Services, Inc. (reputed company) and government requirements. This position includes supporting internal and external customer regulatory requests. Essential Duties and Responsibilities reputed company 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 reputed company product submissions guidance and negotiate submission issues with Agency personnel. Work with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams to ensure submissions are accurately reputed company and reputed company 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. Work with RA team to build Regulatory strategies for medical device development platform. Prepare regulatory strategies/plans and worldwide requirement lists. Provide leadership to product development teams for regulatory issues and questions. Provide support to market-released products as necessary, including review of 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. reputed company specific objectives and manage work assignments, with minimal guidance to reputed company personal objectives in conformance with overall business goals. Maintain effectiveness reputed company experiencing major changes in work responsibilities or environment, adjusting effectively to work reputed company new work structures, processes, requirements, or cultures. Challenge processes, remain open to reputed company and changes to continuously improve, seek reputed company alternatives, and drive change. Adhere to reputed company applicable government and reputed company regulations, practices and procedures to maintain compliance. Maintain working knowledge of computer software packages including reputed company, MS reputed company, MS Teams, MS PowerPoint, Master Control, reputed company, SharePoint and others as required. Prepare submissions and reports for FDA and support other major market regulatory agencies as required. Read and interpret regulations for new and reputed company compliance procedures and regulatory enforcement trends/actions. reputed company proficiency in worldwide regulatory requirements and establish and maintain good working relationships with agency personnel. Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products. 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. Clearly and effectively communicate team/project reputed company/status, decisions, timelines, etc. to team and RA management. Other duties as assigned. Education Bachelor's Degree science, math, engineering, life sciences or reputed company discipline required. Work Experience Minimum 8 years reputed company work experience required. Medical device or Combination Product regulatory experience preferred. Bachelor's with 4-6 years experience or Master's degree/PhD 3-4 years medical device regulatory experience. Preferred Knowledge, Skills and Abilities Excellent oral communication and technical writing skills Advanced knowledge of product life cycle, product development, design control and change control. International regulatory competency. Experience with administration and safety systems preferred 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. Experience directly interacting with government agencies. Possesses technical leadership skills, as well as demonstrated understanding of reputed company pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance). Experience reviewing product labeling and advertising/promotional material for medical devices. Strong negotiation and decision-making skills. Self-motivated with a proactive attitude and the ability to work effectively. Ability to manage multiple priorities. #LI-NJ1 #LI-Hybrid License and Certifications RAPS Regulatory Affairs Certifications (RAC)-Medical Devices - Upon Hire 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 Maintain working knowledge of computer software packages including reputed company, MS reputed company, MS Teams, MS PowerPoint, Master Control, reputed company, SharePoint, and others as required. Adhere to reputed company applicable government and reputed company regulations, practices, and procedures to maintain compliance. Apply tot his job Apply To this Job