Regulatory Affairs Specialist Support global Regulatory Affairs activities for medical devices across product development and lifecycle management. Develop regulatory strategies and submission content for new submissions, renewals, variations, and amendments. Support regulatory activities across international markets including JAPAC, MEAR, and LATAM. Partner with Regulatory Affairs, R&D, Engineering, Manufacturing, and Operations teams to support regulatory approvals. Provide regulatory guidance and support responses to Health Authority questions.
Key Responsibilities:
Develop regulatory strategies and submission content for medical device products with limited management supervision.
Prepare and manage regulatory submissions, renewals, variations, supplements, and amendments.
Support regulatory filings and interactions with Health Authorities across international markets.
Respond to Health Authority questions related to submissions, renewals, and variations.
Represent Regulatory Affairs on product development and lifecycle management teams.
Review engineering study protocols and reports, as well as validation study protocols and reports.
Review and support approval of manufacturing changes for Class IIb medical devices.
Provide regulatory guidance to R&D, Engineering, Manufacturing, Operations, and cross functional teams.
Required Qualifications:
3 to 5 years of direct Regulatory Affairs experience in the medical device industry.
Recent experience with Class IIb EU medical devices.
Strong knowledge of EU MDR 2017/745 regulations.
Proven experience authoring, submitting, and obtaining approval for Class IIb variations and renewals.
Experience supporting device submissions, license renewals, and manufacturing related variations in international markets.
Experience responding effectively to Health Authority questions.
Experience reviewing engineering and validation study protocols and reports.
Preferred Qualifications:
Advanced degree in Regulatory Affairs, Life Sciences, Engineering, or a related field.
Experience supporting regulatory activities across JAPAC, MEAR, and LATAM markets.
Experience with markets such as Singapore, Malaysia, Hong Kong, Vietnam, South Africa, Botswana, Brazil, and Mexico.
Experience supporting cross functional product development and lifecycle management teams.
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually - As Applicable.
