Senior Regulatory Affairs Specialist at Masimo

Job description

Job Summary:

Located in Johannesburg, South Africa, the Senior Regulatory Affairs Specialist will be an integral part of an expanding regulatory affairs team that is responsible for supporting international regulatory registrations and related compliance. Key responsibility is to prepare, submit, and maintain medical device registrations in the assigned countries.

Duties & Responsibilities:

• Process and maintain international filings/registrations in assigned countries within EMEA, with particular focus on African countries.
• Generate and maintain product and process compliance checklists for the assigned countries.
• Maintain up-to-date knowledge on applicable regulatory requirements in the assigned countries, and distribute relevant information internally.
• Liaise with in-country representatives on all matters relative to product and process regulatory requirements.
• Prepare and maintain other regulatory documentation, as needed in the assigned countries.
• Contribute to the implementation of regulatory best practices and efficient processes for regulatory information management.
• Support operations, marketing, and sales with global market approvals for product shipment.
• Generate/update quality system procedures owned by Regulatory Affairs, as required.
• Participate in relevant projects to provide regulatory guidance.
• Perform other duties or special projects, as assigned.

Minimum Qualifications:

• Three or more years of experience in medical device Regulatory Affairs.
• Experience with current EMEA regulations on electro-medical devices.
• Excellent verbal and written communication skills booth in English, French is an asset.
• Experience working remotely with in-country representatives and with USA-based headquarters.
• Excellent prioritizing, organizational and interpersonal skills.
• Willingness to accommodate a flexible working schedule across time zones that may involve evening and weekend working hours depending on project requirements.
• Ability to work in a fast-paced environment, with multiple tasks/projects.
• A detailed-oriented individual with a “can do” attitude and ability to work in a team environment as well as individually with minimal supervision.

Preferred Qualifications:

• 3-5 years of related work experience.
• Experience in patient monitoring systems, hospital-based equipment, software or electronic devices.
• Good knowledge of European Union regulations on electro-medical devices, including wireless and connectivity requirements.
• Experience interacting with regulatory bodies.
• Proficient in document management systems, such as Oracle Agile PLM.
• Prior experience working with in-country representatives in African countries.
• Prior experience working with international organizations.

Education:

BA/BS Degree, or equivalent combination of education and experience is required. Preferred degrees in life sciences or biomedical engineering.

Are you looking for uncommon opportunities with an extraordinary company?