Principal Regulatory Affairs Specialist – CRM

Principal Regulatory Affairs Specialist – CRM

Requirements

• Bachelor’s degree in a technical discipline
• Minimum 7 Years of medical device regulatory experience with Bachelor’s degree
• Or minimum 5 Years of medical device regulatory experience with an advanced degree

Responsibilities

• Prepare worldwide submissions for new products and their product changes as required to ensure timely approval for market release.
• Prepare regulatory strategies/plans and worldwide compliance requirements.
• Provide business and product information to enable development of strategies and requirements, as well as communicate that information to the Project teams.
• Provide regulatory support for currently marketed products as necessary.
• Complete understanding and wide application of technical or regulatory principles, theories and concepts.
• Negotiate with international agencies, as needed.
• Participate in the project team meeting to plan strategies, including reviewing the various specifications and plans/reports, defining target market and distribution method, Medtronic requirements on testing, etc.
• Provide regulatory analysis of product portfolio and review with other functional resources, such as Marketing, Global Supply Chain, etc., to ensure Diagnostics and EPG portfolio is aligned with existing portfolio.
• Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
• Work under general supervision following established procedures.
• Independently determines and develops approach.
• Frequent inter-organizational contact and some external contacts.
• Keeps current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas.
• Provide training and support to other members of the department.
• Other tasks, as required.

Preferred Qualifications

• Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA and PMDA), and working with cross-functional project teams.
• Master of Science Degree
• In depth experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
• History of successful device submissions
• Strong negotiation skills and written/oral communication skills
• Strong organizational skills and time management skills
• Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
• Ability to work independently and under general direction only
• Computer skills; MS Office, MS Project, Adobe Acrobat and Agile