Current jobs related to Senior Regulatory Affairs Manager - Lake County - Katalyst HealthCares & Life Sciences
-
Regulatory Affairs Associate I
3 days ago
Lake County, United States Katalyst HealthCares & Life Sciences Full timeJob Description:The Regulatory Affairs Associate will be responsible for managing, authoring, and compiling Chemistry, Manufacturing, and Control (CMC) sections of regulatory submissions for marketed product variations, including Class III implantable medical devices. This position involves coordinating cross-functional activities to ensure timely and...
-
Regulatory Affairs Specialist
3 weeks ago
Salt Lake City, United States Utah Staffing Full timeRegulatory Affairs SpecialistAn RA Specialist on the Regulatory Affairs Lifecycle Management (RA LCM) team is responsible for developing regulatory strategies and assessing regulatory risks related to product changes throughout their life cycle. This role focuses on driving post-market changes (to include design, manufacturing, and labeling updates) through...
-
Regulatory Affairs Specialist
21 hours ago
Salt Lake City, UT, United States Biomerieux Full timeDescription Position Summary: An RA Specialist on the Regulatory Affairs Lifecycle Management (RA LCM) team is responsible for developing regulatory strategies and assessing regulatory risks related to product changes throughout their life cycle. This role focuses on driving post-market changes (to include design, manufacturing, and labeling updates)...
-
Senior Analyst, Regulatory Affairs
4 weeks ago
Eagle Lake, United States First Quality Full timeOverview Founded over 35 years ago, First Quality is a family-owned company that has grown from a small business in McElhattan, Pennsylvania into a group of companies, employing over 5,000 team members, while maintaining our family values and entrepreneurial spirit. With corporate offices in New York and Pennsylvania and 8 manufacturing campuses across the...
-
Executive Director Of Regulatory Affairs
2 weeks ago
Woodcliff Lake, United States LLoyd Staffing Full timeExecutive Director, Regulatory Affairs (Neurology) – Detailed SummaryLocation: Northern, NJ (Hybrid – 3 days/week onsite)Salary: $270K–$350K + BonusThis senior leadership role is responsible for developing and executing global regulatory strategies for neurology drug programs at a fast-growing, research-driven pharmaceutical company. The Executive...
-
Regulatory Affairs Specialist
2 weeks ago
Salt Lake City, United States bioMerieux Inc. Full timeDescription Position Summary:An RA Specialist on the Regulatory Affairs Lifecycle Management (RA LCM) team is responsible for developing regulatory strategies and assessing regulatory risks related to product changes throughout their life cycle. This role focuses on driving post-market changes (to include design, manufacturing, and labeling updates) through...
-
Regulatory Affairs Specialist
3 days ago
Salt Lake City, UT, United States bioMerieux Inc. Full timeDescription Position Summary: An RA Specialist on the Regulatory Affairs Lifecycle Management (RA LCM) team is responsible for developing regulatory strategies and assessing regulatory risks related to product changes throughout their life cycle. This role focuses on driving post-market changes (to include design, manufacturing, and labeling updates)...
-
Regulatory Affairs Specialist
15 hours ago
Salt Lake City, UT, United States bioMerieux Inc. Full timeDescription Position Summary: An RA Specialist on the Regulatory Affairs Lifecycle Management (RA LCM) team is responsible for developing regulatory strategies and assessing regulatory risks related to product changes throughout their life cycle. This role focuses on driving post-market changes (to include design, manufacturing, and labeling updates)...
-
Sr Regulatory Affairs Manager
3 weeks ago
Round Lake, United States Gandiv Insights LLC Full timeWe’re looking for a seasoned Regulatory Affairs professional to lead global nonclinical and clinical regulatory strategy for programs across their full lifecycle. This high-impact role partners with cross-functional leaders, guides Health Authority engagement, and drives critical global submissions. What You’ll Do Lead development and execution of global...
-
Director, Regulatory Affairs
6 days ago
Salt Lake, Utah, United States BD Full time $150,000 - $200,000 per yearJob Description SummaryJob DescriptionWe are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech...
Senior Regulatory Affairs Manager
2 weeks ago
Responsibilities: Prepare, review, and submit regulatory documents to FDA. Manage and oversee the regulatory submission process, ensuring timely and successful clearances/approvals. Ensure that all products comply with applicable regulatory requirements, including FDA regulations and ISO standards. Provide regulatory guidance to R&D team during product development life cycle. Stay updated on changes in regulatory requirements and communicate potential impacts to the organization. Conduct regulatory assessments for product changes and provide recommendations for appropriate regulatory pathways. Collaborate with internal stakeholders and external partners to ensure alignment on regulatory strategies and project timelines. Represent the company in meetings with regulatory agencies and external partners as needed. Ensure proper documentation and maintenance of regulatory submissions and correspondence with regulatory agencies. Requirements: Master's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field; advanced degree preferred. Minimum of - years of experience in regulatory affairs within the medical device industry. Proven track record of leading and successfully obtaining (k) and De Novo clearances/approvals. Experience in interacting with FDA and other regulatory agencies. In-depth knowledge of FDA regulations, CFR Part , ISO , and other applicable medical device regulations. Strong leadership and project management skills, with the ability to manage multiple projects and priorities. Excellent communication, negotiation, and problem-solving skills. Ability to work collaboratively in a cross-functional team environment. Detail-oriented with strong organizational skills.
