Regulatory Affairs Specialist

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

As a Senior Regulatory Affairs Specialist, you will work independently with limited directions from your supervisor to ensure market access and market continuity by executing product registrations and ensuring regulatory compliance in Singapore and Export Markets.

What will you be doing?

• Ensure regulatory compliance in Singapore and Export Markets

• Compile registration dossiers for new product registrations or change notifications according to regulatory plan and local regulatory requirements.

• Submit product registrations or change notifications to the relevant regulatory authorities and obtain approval timely.

• Submit license renewals timely.

• Report Field Safety Corrective Actions and Adverse Events to the regulatory authority.

• Assess impact of changes initiated by Product Owner and work closely with the supply chain, manufacturing and commercial teams to ensure no disruption to supply.

• Provide internal stakeholders with regular updates throughout the registration process.

• Review promotional materials in accordance to the local advertising code and guidelines.

• Maintain regulatory databases or systems.

• Develop regulatory strategy for new product development projects

• Maintain current knowledge of applicable laws, regulations and industry standards, provide guidance in interpreting regulations and conduct impact assessments due to the changes.

• Provides regulatory guidance and mentoring to junior Regulatory Affairs colleagues

• To always act in a responsible manner to avoid risk to self or to the company and comply with the workplace safety and health and security policy.

• Any other duties involved within the role and/or the tasks as assigned from time to time

What will you need to be successful?

Success in the role will require a combination of technical knowledge, soft skills, and a deep understanding of both the business and service-providing sides of an organization. Successful candidates would need the following:

• Bachelor degree in any engineering or science related discipline.

• At least 5 years’ RA experience in in medical device Industry

• Detailed knowledge of the regulatory controls of medical devices in Singapore and Export Markets