Responsibilities of the Regulatory Affairs Associate:

• Provide regulatory input to product lifecycle planning. Assist in SOP development and review.
• Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
• Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.

• Determine trade issues to anticipate regulatory obstacles. Participate in risk benefit analysis for regulatory compliance.
• Determine and communicate submission and approval requirements. Monitor applications under regulatory review.
• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
• Assist in preparation and review of regulatory submission to authorities.
• Maintain annual licenses, registrations, listings and patent information.
• Assist compliance with product postmarketing approval requirements. Assist in the review of advertising and promotional.

items.

• Assess external communications relative to regulations. Review regulatory aspects of contracts.
• Assist with label development and review for compliance before release.
• Submit and review change controls to determine the level of change and consequent submission requirements.
• Contribute to the development and functioning of the crisis/ issue management program. Ensure product safety issues and product associated events are reported to regulatory agencies.

• Provide regulatory input for product recalls and recall communications.
• Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.
• Establishes and cultivates an extensive network of support to facilitate completion of assignments.

• Participates in determining goals and objectives for projects.
• Influences middle management on technical or business solutions.
• May interact with vendors.
• Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious delays and considerable expenditure of resources.

Requirements of the Regulatory Affairs Associate:

• Bachelors Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
• Experience/Background: Minimum 2 years in medical device industry.

Preferred Qualifications

• 2-3 years’ experience in a regulated industry (e.g., medical products, nutritional’s). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Experience with Regulatory history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel.
• Principles and requirements of applicable product laws; Submission/registration types and requirements; GxPs (GCPs, GLPs, GMPs); Principles and requirements of promotion, advertising and labeling; Domestic and international regulatory guidelines, policies and regulations; Ethical guidelines of the regulatory profession, clinical research and regulatory process. Note: This knowledge may be developed through tenure in this position.
• Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel. Write and edit technical documents.
• Work with cross-functional teams. Work with people from various disciplines and cultures.
• Write and edit technical documents.
• Negotiate internally.
• Pay strong attention to detail.
• Manage projects. Create project plans and timelines.
• Think analytically and critically.
• Organize and track complex information.
• Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Has a sound knowledge of a variety of alternatives and their impact on the business.
• Apply business and regulatory ethical standards.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.