**Job Title**: International Regulatory Affairs Specialist (LATAM)
International Regulatory Affairs Specialist (LATAM)
**Your role**:
- Be considered a key regulatory point person to enable regulatory compliance in Markets where Philips Image Guided Therapy products are commercialized.
- Be an impactful member of the Regulatory Affairs (RA) team and trusted by management as an independent regulatory team member on multiple projects simultaneously.
- Support multiple projects, function on a multi-geography basis, prioritize, conduct team meetings, and meet project deadlines.
- Ensure completion of the Registration Annual Schedule in countries under responsibility and, report progress per established KPIs to introduce new products and keep continuous products access to the Markets.
- Anticipate and communicate regulatory requirements for the countries under responsibility. Act as Subject Matter Expert (SME) during the implementation of design changes induced by the country's regulation.
- Oversee the regulatory strategies for registration and compliance of IGT-D therapies and document them in the Regulatory Plans for the countries under responsibility.
- Support MDSAP Audits for all manufacturing sites related to IGT-D therapies.
- Oversee the execution of the Regulatory Plans and implement a First-time right submission culture (for Registrations, Re-Registrations, and Renewals)
- Able to professionally negotiate and lead meetings with internal and external customers (Marketing, R&D, Markets, Distributors). All significant issues are escalated on time and discussed with the RA Regional Managers.
- Implement an audit-ready culture.
- Monitors the regulatory environment (specific regulations, guidance, and other relevant information by product types, geography, etc.), maintains information resources, and disseminates changes/updates as needed.
- Assesses the potential impact from new guidance and regulations.
- Keep abreast of Regulatory changes, perform regulatory gap analysis, and prepare the communications for Request for Solutions (RfS) to the Product Safety Review Board (PSRB) or other forums as needed.
- Interface with regulatory agencies and distribution partners as needed.
- Identifying Process optimization to strengthen the International Regulatory Department and implement required improvements.
- Engages in continuous learning activities to maintain technical competence in the product areas supported.
- Providing accurate and consistent regulatory recommendations, decisions, and feedback to RA stakeholders. Communicates with knowledge, consistency, and clarity to maintain integrity and impact of the message.
- Able to identify risks within regulatory strategies and communicate risks to project teams and RA management. Communicates with knowledge, consistency, and clarity to maintain integrity and impact of the message.
- Following Quality System procedures to ensure compliance with all other applicable regulations.
- Maintaining proficiency in broad, regional regulatory requirements. Develop general strategies on more effective interactions with government agencies and agency personnel. As with local trade associations.
- Assisting the Regulatory Affairs Management with training of more junior specialist staff.
- Mentoring other Regulatory Affairs personnel
**You're the right fit if**:
You have the following:
- A local work authorization is a precondition of employment.
- BS degree in a relevant field. (BS, MS, or PhD in Engineering or Science preferred.)
- 5+ years of medical device experience with BS degree and work experience in Regulatory Affairs, or 3+ years of medical device experience with MS degree and work experience in Regulatory Affairs, or 2+ years of Regulatory Affairs experience with PhD in Engineering/Science.
- Excellent communication both written and verbal as well as experience with communication and presentations to senior leadership.
- Demonstrated experience in multiple types of International regulatory submissions (Latin America, Brazil, among others)
- Must have working knowledge of ANVISA, INMETRO, ANATEL, and LATAM regulations and other applicable regional regulations for handling complaints, reporting incidents, and implementing corrective and preventative actions including US FDA, ISO 13485, and EU MDR.
- Ability to make decisions promptly, sometimes with incomplete information and under tight deadlines.
- Knowledge of PC hardware/software, documentation, and archives (Proficiency in Microsoft Office Suite, particularly Word and Excel)
- Languages: Professional proficiency in English (written and spoken), Portuguese (written and spoken), Spanish (written and spoken), and knowledge of other languages is an asset.
LI-PH1