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Job Summary

This Regulatory Affairs Manager position is an onsite opportunity. The candidate will combine knowledge of scientific, regulatory, and business issues to enable products, including combination products, that are developed, manufactured or distributed to meet required legislation. This new team member has department/group/site level influence and is generally recognized as an expert resource and mentor within the department.

Job Responsibilities

• Develop new regulatory policies, processes and SOPs and train key staff on them.
• Evaluate regulatory risks of division policies, processes, procedures.
• Provide regulatory input to product lifecycle planning.
• Provide strategic input and technical guidance on regulatory requirements to development teams.
• Prepare robust regulatory applications (FDA and international regulatory agencies) to achieve departmental and organizational objectives.
• Assist in the development of multi-country regulatory strategies and update strategy based upon regulatory changes.
• Support pre and post approval clinical strategy and submission activities.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Assess the acceptability of development, quality, preclinical and clinical documentation for submission filing.
• Compile, prepare, review and submit regulatory submissions to authorities.
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
• Ensure compliance with US and global product post marketing approval requirements.
• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
• Execute and manage technical and scientific regulatory activities.
• Must function independently as a decisionmaker on regulatory issues and must assure that deadlines are met.
• Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies.
• Properly interpret and apply regulatory requirements.
• Interface with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.
• Provide leadership and guidance towards achieving department objectives and act as a mentor to less experienced staff.
• May supervise exempt or non-exempt employees.
• May lead a cross-functional or cross-divisional project team.
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Required Qualifications

• Bachelor's Degree in a related field OR an equivalent combination of education and work experience
• Minimum 4 years of experience in a regulated industry (e.g., medical products, nutritionals).
• 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related areas. Note: Higher education may compensate for years of experience.
• Ability to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with diverse audiences.
• Domestic and international regulatory guidelines, policies and regulations.
• Lead functional groups in the development of relevant data to complete a regulatory submission.

Preferred Qualifications

• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
• Master's or Ph.D. in a technical area.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
• Previous experience with US (e.g. PMA, PMA/S, IDE, 510(k), etc.), CE (EU MDR) and international submissions.
• Experience with Class II and Class III medical devices.
• Ability to define regulatory strategy.
• Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
• Experience with post-approval manufacturing and design changes.
• Ability to work effectively on cross-functional teams.
• Strong attention to detail.
• Experience with organizing and tracking complex information.
• Able to juggle multiple and competing priorities.
• Experience with exercising judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Has broad knowledge of various technical alternatives and their potential impact on the business.
• Uses in-depth knowledge of business functions and cross group dependencies/ relationships.