Sr Regulatory Affairs Specialist.

Careers that Change Lives

The Senior Regulatory Affairs Specialist is responsible for developing regulatory strategies, preparing U.S. and EU submissions and maintaining approval for products.

Additionally, the Senior Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes.

A Day in the Life

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications.
• Responsible for reporting complaints and Adverse Drug Reactions (ADR)
• Define the regulatory strategy and manage regulatory submission activities for product maintenance for existing approved products.
• Team with operating unit Regulatory Affairs Specialists (RAS) and international

regulatory team to provide regulatory support changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.

• Prepare regulatory (e.g., FDA / Notified Body) submissions for product changes, as required, to ensure timely approvals for market release.
• Review significant product submissions with manager and negotiate submission issues with agency personnel.
• Provide support to currently marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval.
• Interact directly with FDA / Notified Body and indirectly with international regulatory agencies on most projects / products at reviewer level.

All significant issues will be reviewed with the manager.

• Support regulatory compliance activities, including manufacturing site registration, audits, etc., as needed.
• Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
• Provide business and product information to international regulatory team to enable development of strategies and requirements and communicate that information to business teams.
• Ensure personal understanding of all quality policy / system items that are personally applicable.
• Follow all work / quality procedures to ensure quality system compliance and high quality work.

Must Have : Minimum Requirements

KNOWLEDGE / EDUCATION

• Bachelor’s degree, or;
• Advanced degree.
• Knowledge of products and therapies.

JOB EXPERIENCE

• Minimum of 4 years of relevant experience, with a bachelor’s degree, or
• Minimum of 2 years relevant experience, with an advanced degree.
• Experience in Regulatory Affairs or related field
• Proven experience with drug or device regulatory / submission process.
• Regulatory Agency experience.
• Business Development.

SKILLS / COMPETENCIES

• Demonstrated leadership competencies.
• Effective at influencing and building strong working relationships across all levels.
• Negotiation Skills.
• Technology Expertise.
• Business Acumen.
• Demonstrated organizational abilities.
• Good Communication skills.
• Excellent Computer Skills.
• Medtronic Competencies.
• Strong interpersonal and communication skills at all levels of the organization.
• Proven track record of good judgment.
• Demonstrated integrity and respect for all.
• Attention to detail.
• Strong problem solving and results driver.
• Ability to manage multiple priorities in a fast-paced environment.

Nice to Have

KNOWLEDGE / EDUCATION

• RAC certification Salary Range : 86K - 129K
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