Regulatory Affairs Manager
Regulatory Affairs Manager
Posted on :
16-09-2025
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1 Vacancy
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Job Description
Responsibilities:
- The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS) Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products including regulatory responsibilities in associated change control and labeling processes.
- This person is instrumental in the design development and maintenance of global regulatory processes and business solutions.
- This is a meaningful individual contributor who will partner with key business functional and business partners to ensure commercial objectives are achieved.
- Accountable for all operational aspects including owning creating and/or maintaining CCDS/CCSI/RSI documentation delivering maintaining and driving regulatory systems databases and labeling processes that support therapeutic and combination products.
- Lead the initial development approval and ongoing compliance of product labeling content throughout the product life cycle; track status and maintain documents in controlled process and systems workflows; lead reviews and manage the documents through approvals and governance by cross-functional executive and subject matter authority leadership.
- Make decisions regarding patient safety signals indications risk and other sophisticated change or regulated content creation/modification triggers.
- Support global implementation of CCDS/CCSI/RSI into country-specific labeling by developing and approving implementation of complex global and local labeling and other regulated solutions in accordance with the end-to-end regulated content labeling processes and commercial objectives including reviewing deviations exemptions and deferrals.
- Participate in the execution of regulatory labeling and content strategies for new products and ongoing compliance for products already on the market including monitoring evaluating and internally communicating new and existing applicable regulatory requirements.
- Lead or support global technology process and solution initiatives to standardize and enable standard process in labeling and content management including requirements use cases and translations.
- Deliver responses solutions and find opportunities to improve based upon quality initiatives including audits and risk mitigation.
- Perform gap analysis on regulated content management processes; design develop assess improve implement and maintain associated complex and simple Global Regulatory Affairs and Quality processes and business solutions.
- BS/MS degree or equivalent experience required.
- Expertise with global medical device regulations and registration processes especially USA 510(k) and EU MDR.
- Superior presentation skills when communicating with all levels of the organization business partners and external sources.
- Ability to work with evolving technologies systems and global teams in a fast-paced matrixed environment.
- Department of Commerce through the Export Administration Regulations (EAR) by the Department of State through the International Traffic in Arms Regulations (ITAR) and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.
Employment Type
Full-time
Key Skills
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