Job Description:
Safety Manager, Japan Regulatory Affairs
3M 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 a Safety Manager, 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:
- Taking Safety Manager responsibility of Marketing Authorization Holder as defined by Pharmaceutical and Medical Device Act and Good Vigilance Practice (GVP) for Medical Device, Drug, Quasi Drug and Cosmetic registered by Solventum Japan Innovation Limited.
- Planning and implementation of safety assurance measures, including reporting to the Pharmaceutical and Medical Device Agency (PMDA), based on the evaluation of safety information collected both domestically and internationally.
- Provision of necessary information for vigilance reporting to regulatory authorities in each country.
- Employee training and education to maintain a compliance framework with relevant laws and regulations.
- Collaboration with business units to provide appropriate usage information to healthcare institutions, and to enhance corporate brand value through Risk Management Process and IFU maintenance.
- Collaboration with Global vigilance teams through Compliance Quest responsibilities.
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 from an accredited institution AND (3) three years of experience of safety assurance measures or other similar duties as defined below.
- Post-marketing surveillance management duties as stipulated in the GPSP Ministerial Ordinance for pharmaceuticals, medical devices, or regenerative medical products (hereinafter referred to as the "GPSP Ordinance"), including the responsibilities of the Post-Marketing Surveillance Management Officer.
- Duties related to reexamination or reevaluation as defined under the GPSP Ordinance.
- Duties related to periodic infection reporting under Article 68-8 of the former Pharmaceutical Affairs Law, or adverse event reporting under Article 77-4-2 of the same law.
- developing, supporting and/or maintaining commercialized products in a private, public, government environment.
In addition to the above requirements, the following are also required:
- Strong communication skills (written, oral, and presentation) and systems proficiency in Japanese
- Sufficient communication skills (written, oral, and presentation) and systems proficiency in English.
- Experience collaborating with laboratory, quality, regulatory, and manufacturing functions.
Additional qualifications that could help you succeed even further in this role include:
- Three (3) years of Regulatory Affairs, Quality Assurance, Clinical or Laboratory in the medical device or drug industry.
- Competencies in one or more of the following areas:
- Experience on writing technical documents in English or Japanese.
- Experience on creating Local Instructions for Use in Japanese.
- Communication with regulatory authorities.
- Knowledge of QMS including risk management and change management, regulatory submission, audit, familiarity with qualification procedures (process validation, design verification), and competency in creative problem solving.
- Demonstrated use of project management techniques to lead cross functional teams in projects that drive improvement and results.
Work location: Shinagawa Head Office
· Hybrid (Onsite and Remote): Eligible
Travel: May include up to 3% domestic
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).
Supporting Your Well-being
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.
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Top Skills
What We Do
At Solventum, we enable better, smarter, safer healthcare to improve lives. We never stop solving for you
