Regulatory Affairs Contractor

This is a fully remote position, open to applicants in Colombia.

📋 Description

• Assist in regulatory functions related to the integration of medical device products and portfolios into current business processes and systems.

• Create, revise, and uphold Global Regulatory Plans (GRPs) and the corresponding regulatory documentation.

• Aid in global product registrations, renewals, license maintenance, and fulfill other market-specific regulatory obligations.

• Evaluate the regulatory implications of changes concerning products, manufacturing, labeling, suppliers, sites, and quality systems.

• Support regulatory tasks linked to transitions of legal manufacturers, manufacturing sites, and quality systems.

• Collaborate with regional Regulatory Affairs teams to pinpoint country-specific requirements and implement the necessary regulatory actions to sustain market access.

• Assist with EU MDR and other global regulatory lifecycle tasks, including updates to technical documentation, assessments, submissions, and notifications.

• Examine existing regulatory documentation, identify deficiencies, and coordinate actions needed to facilitate integration and maintain ongoing compliance.

• Keep regulatory trackers, plans, and deliverables updated, ensuring activities are completed within established timelines.

• Work in partnership with Quality, Operations, R&D, Clinical, Supply Chain, and other cross-functional stakeholders to support integration efforts.

• Recognize and escalate regulatory risks, dependencies, and potential impacts on business or integration timelines.

⛳️ Requirements

• A Bachelor's degree in life sciences, engineering, Regulatory Affairs, or a related field.

• 3–5+ years of experience in medical device Regulatory Affairs is preferred.

• Familiarity with global medical device registrations and lifecycle management.

• Solid understanding of FDA medical device requirements and EU MDR.

• Experience with additional international markets is a plus.

• Background in conducting regulatory change assessments, global regulatory planning, and/or business or product integration activities is preferred.

• Capability to independently manage multiple regulatory deliverables while collaborating effectively with global teams.

• Excellent organizational, written communication, and problem-solving abilities.

• Experience with Class II/III medical devices, global regulatory plans, EU MDR, regulatory change assessments, and the integration or transition of established medical device portfolios is highly desirable.

• Successful completion of employment verification and background checks is required.

• Employment verification to confirm job titles and employment dates with two previous employers.

🏝️ Benefits

• Competitive compensation paid in USD.

• 20 days of paid time off (PTO) annually.

• Opportunities for professional growth and career development.

• Company-provided equipment.

• A collaborative, inclusive, and multicultural work environment.

• The chance to contribute to meaningful projects alongside a talented and supportive team.