Associate Regulatory Affairs Specialist

About the role

The Associate Regulatory Affairs Specialist position within the Cardiac Ablation team focuses on supporting the products of this business. This role involves international regulatory affairs, regulatory operations, and project coordination.

Responsibilities

• Understand global regulatory requirements and research detailed requirements.
• Contribute to global product registration maintenance, including EU MDR Technical Documentation/MDD Technical Files.
• Assess device changes for registration implications and electronically notify geographies of regulatory changes.
• Routinely route regulatory documents for approvals in electronic systems, maintain approval information, and maintain electronic document collections.
• Support requests to systems relating to product release, economic operator verification, and registration and listing.
• Participate in preparation for internal and external regulatory audits.
• Compile materials required for new global product submissions, license renewals, and change submissions.
• Maintain and improve global regulatory tracking/control systems.
• Request, obtain, and maintain FDA Certificate of Foreign Government (CFGs) including notarization and legalization, EC/ISO certificates, and various other regulatory documents.
• Stay updated on regulatory procedures and changes.
• Perform other regulatory duties as needed.

Requirements

• Bachelor's degree
• 0 years of regulatory affairs or related experience

Qualifications

• Bachelor’s Degree in a health profession, science and/or engineering field
• Experience in medical device industry
• Demonstrated technical writing skills
• Strong computer skills, including word processing, excel, and project management tools
• Excellent organizational, project management skills
• Strong written, verbal, and interpersonal skills

Benefits

Competitive Salary and flexible Benefits Package including health, dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

Regular employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Temporary employees are eligible for paid sick time, as required under applicable state law.

For more details, please refer to the Medtronic Benefits and Compensation Plans.