Regulatory Affairs Specialist

The Regulatory Affairs Specialist supports the regulatory activities required for global market entry and patient access for Elixir Medical’s growing product portfolio.  In this role they will contribute to the development and updating of regulatory strategies, submission, and documents based upon regulatory changes. This position performs specialized level work assignments in the evaluation, preparation, and submission of documentation for worldwide regulatory registrations, ensuring products and procedures comply with regulatory requirements.

Major Duties and Responsibilities

• Contribute to the development and implementation global regulatory strategies that support clinical research and marketing approvals in accordance with the company’s strategic objectives
• Monitor and analyze appropriate regulatory agency activities in areas of interest to the company
• Organize and prepare clear and effective submissions for clinical studies and commercial approvals
• Prepare and deliver effective presentations for external and internal audiences
• Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position
• Provide regulatory support on R&D project teams including:
• Formulation and implementation of regulatory strategy
• Identification and assessment of associated regulatory risks and strategies to mitigate risks
• Input/guidance regarding development and testing strategies needed for regulatory approvals
• Resolution of complex issues
• Achievement of company timelines and milestones
• Provide regulatory support for Operations projects
• Provide regulatory support for Sales and Marketing materials and strategies

GENERAL

• Maintains a professional and credible image with key physicians, consultants, suppliers, and co-workers
• Supports company goals and objectives, policies and procedures, ISO 13485, FDA QSR, EU MDD/MDR and other applicable international regulations and standards
• Performs other duties as assigned

Qualifications

Experience                                            

• Minimum 1 year of medical device experience, preferred regulatory or quality experience
• Preferred experience with Class III or cardiovascular device registrations including FDA, EU, and other international medical device regulations and submissions
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment
• Ability to leverage and/or engage others to accomplish projects
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Multitasks, prioritizes and meets deadlines in timely manner
• Strong organizational and follow-up skills, as well as attention to detail
• Proficient with MS Office suite of products

Education Requirements

• BA or BS degree; technical discipline preferred

Last Revision Date: August 11, 2020

Elixir Medical does not discriminate on the basis of race, sex, color, religion, marital status, national origin, gender, sexual orientation, gender identity, age, military veteran status, disability or any other reason prohibited by law.