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Regulatory affairs director, apac
2 months ago
Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3 M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3 M branding. Please bear with us. In the interim, our Privacy Policy here: continues to apply to any personal information you submit, and the 3 M-branded positions listed on our Careers Page are for Solventum positions. As it was with 3 M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Job Description: 3 M Health Care is now Solventum At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you. The Impact You’ll Make in this Role As the Regulatory Affairs Director, you will lead the APAC Regulatory Affairs team - a functional area that is strategic and has corporate-wide impact. This role will serve as a primary point of contact for the APAC team members and as a key contributor to governance decisions for strategic alignment and direction for the area. You will actively build strong relationships across stakeholders, management, and with contract organizations. You will be responsible for developing a team that has the appropriate capacity and competence to support the strategic plans of the business. As the Regulatory Affairs Director, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by: Developing and executing regulatory strategies to achieve product approvals faster than competitors. Directing complex decision making among stakeholders and senior leaders in an area of regulatory that is complex and evolving. Advising and guiding the regulatory strategy development, Health Authority interactions, and submission activities to support the Med-Surg and Dental Solutions product portfolios. Collaborate with internal teams, including R&D, Quality Assurance, and Clinical Affairs, to ensure regulatory requirements are integrated into product development and lifecycle management processes. Participate in global business and functional strategic leadership meetings and forums representing regulatory affairs perspective while supporting the Med-Surg and Dental Solutions business. Mentoring and guiding regulatory staff and teams working across all product modalities. Establishing goals and objectives. Your Skills and Expertise To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications: Bachelor's degree or higher in a Science or Engineering discipline Ten (10) or more years of Regulatory Affairs experience in the medical device industry. In addition to the above requirements, the following are also required: Master’s degree in a Science or Engineering discipline Previous Medical Device / Healthcare experience Ability to manage, direct, and develop a team located in multiple countries, including China and Japan Excellent verbal and written communication skills in English Deep regulatory experience across multiple APAC countries Detail oriented with the ability to navigate matrix environment Work location: Remote – must reside in an APAC country Travel: May include up to 25% domestic/international Relocation Assistance: Is not authorized Must be legally authorized to work in the country of employment without sponsorship for employment visa status (e.g., H1 B status). Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope. Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers. Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com . Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains. Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly. Solventum Global Terms of Use and Privacy Statement Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms. Please access the linked document by clicking here, select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with theterms. Be careful - Don’t provide your bank or credit card details when applying for jobs. Don't transfer any money or complete suspicious online surveys. If you see something suspicious, report this job ad. Sign in to start saving jobs in your profile. Don’t have a jobs DB account? Register with: Do you want to receive recommendations for similar jobs? #J-18808-Ljbffr
