Hybrid Regulatory Affairs and Compliance Specialist (Malaysia/Singapore) at 3M HEALTHCARE

Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M 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 3M branding. Please bear with us. In the interim, our Privacy Policy here: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ continues to apply to any personal information you submit, and the 3M-branded positions listed on our Careers Page are for Solventum positions. As it was with 3M, 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:

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 MY/SG Regulatory Affairs & Compliance Specialist, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world.

• Responsible for pre-market regulatory clearances and post-market regulatory activities.

• Perform regulatory assessment and determine registration plans with business divisions for strategic implementation.

• Articulate registration requirements and compile regulatory documents according to local regulatory requirements.

• Submit registration dossier and follow through all in-process evaluation until regulatory clearance is obtained.

• Act as the focal point for commercial support pertaining to all regulatory activities.

• Manage regulatory systems and tools to drive operational excellence for effective data tracking and ensure regulatory data integrity.

• Responsible for post-market regulatory activities to ensure regulatory compliance.

• Execute all warranted FSCA and follow-up all through until closure, including preparation and submission of relevant FSCA reports to regulatory authority.

• Perform adverse event reporting and follow-up through until closure.

• Review promotional materials to ensure all business claims in the range of registered scope. 

• Remain good rapport with regulatory authority and regulatory industry to assure the partnership and support effective regulatory policy.

• Keep abreast of new regulations and provide necessary regulatory information, updates, and documentation to organization.

• Support any other duties within the role or task assigned from time to time.

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 Pharmacy, Life Sciences, or a related scientific field.

• 2 – 3 years of regulatory affairs experience in pharmaceutical and/or medical devices industry.

Additional qualifications that could help you succeed even further in this role include:

• Knowledge of ASEAN Medical Devices and Cosmetics regulatory requirements.

• Experience in Dental devices preferred.

• Excellent communication and collaboration abilities.

• Independent and proactively working on regulatory support.

• Team player to support different directions of group work.

• Flexible attitude and ability to work in a rapidly changing regulatory environment.

Work location: Work Your Way eligible (Employee choice to work remote, on site, or hybrid)

 

Travel: May include up to 5% (domestic/international)

 

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.

Diversity & Inclusion

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, gender, sexual orientation, age, civil status, disability, family status, or membership of the travelling community.

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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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 the
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