Regulatory Affairs and Compliance Specialist

7 days ago

Singapore Solventum Full time

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._

We currently have an opening for a Regulatory Affairs and Compliance Specialist, with below primary scope:
1. Responsible for all activities pertaining to the relevant regulatory licenses and requirements for export market of SEA businesses to support distributors to grow business.

2. Responsible for all post-market regulatory activities for all registered products for export market of SEA businesses to keep distributors compliance.

3. Support QMS audit and certification in Export Market for good distribution practice to maintain the product safety and performance as claimed by Legal Manufacturer.

4. Responsible for special authorization route for import for re-export products to support import compliance.

5. Work as “go to person” to provide regulatory consultation to support business strategic plan.

6. Remain good rapport with regulatory authority and health care industry to assure the teamwork and industry partnership to support effective regulatory policy.

7. Work on the special project assigned by the leader to support business purposes.

8.Assist Leader for the following RegDesk Change Assignment
- Hold CCP Communication and deployment in APAC (Asia&GCA)
- Laise with SOS RA to task CCP in RegDesk with timely manner
- Follow up with country CCP RA owner to ensure the task executed properly
- Support CCP training in APAC for continuous improvement
- Monitor CCP key metrics in reasonable regulatory timelines.
- Collaborate with Regional Supply Chain team on PIPO due to CCP plan

Qualifications:

- Education: Bachelor of Science or Biomedical Science related
- Relevant Experiences in health care industry required
- Around 2-3 years of regulatory working experiences, preferably in medical device industry
- Knowledge of quality management systems or health care regulatory requirements
- Knowledge of AMDD requirement preferred
- Strong communication and inter-personal skills
- Independent and proactively working on business solutions.
- Team player to support different directions of group work

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.

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