Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Location: Rockville, MD (hybrid or fully remote)
Key skills: Substantive editing, author management, content management
Experience: 8-10 years editorial experience in book publishing
Reports to: Director, Publications
Start date: February 2024
Applicants who are invited to interview will be asked to provide a writing sample.
The Role
Help support the professionals who bring lifesaving medications and medical devices to market! RAPS (the Regulatory Affairs Professionals Society) is seeking a senior editor to shepherd subject matter experts and shape the content they create for books and related products.
What you will do with us:
What you will bring to succeed:
Preferred:
What RAPS offers:
About RAPS
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of professionals involved with regulatory and quality for healthcare products, including medical devices, pharmaceuticals and biologics, diagnostics, and digital health. Founded in 1976 as a neutral, nonprofit organization, RAPS supports and elevates the regulatory profession with education and training, professional standards, publications, research, networking, career development, and other valuable resources. RAPS is home to the Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. The society is headquartered in suburban Washington, DC, with chapters and affiliates worldwide.
As an employer, RAPS encourages dedication to quality and member service. We support innovation and creativity, respect, and high ethical standards. We value learning and professional development and strive to maintain a safe and enjoyable work atmosphere that promotes collegiality.
RAPS provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable laws. RAPS complies with applicable state and local laws governing nondiscrimination in employment in every location where the company has facilities.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
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