The RA Manager provides SME support to project teams supporting new product development projects (premarket) and existing projects (postmarket) that have already received market clearance/approval. The RA Manager gathers data and required documents for domestic and international submission purposes, develops Regulatory Strategies for new products or changes to existing products, maintains existing registrations, supports change management and the review/approval of marketing materials, as well as maintains Regulatory databases for ready reference of international and domestic regulatory staff. He/She applies technical quality and regulatory protocols and methods to ensure activities are in compliance with company standards and regulatory requirements. The Manager provides SME Regulatory Leadership for responsible/assigned regions and projects and is able to work independently with limited supervision.

As an individual contributor, the function of the Manager, Regulatory Affairs is to support the Regulatory Affairs Department ensuring compliance with company standards and the applicable US  and international regulations in which the company does business. The individual will execute tasks and play a consultative role by effectively and collaboratively partnering across internal business functions to achieve goals and objectives. The individual may also have/lead discussions with Regulatory Bodies. The RA Manager may have direct reports which will include management and development responsibilities.

Customers include;

• Internal departments needing quality and regulatory services and support (marketing, regional management, customer service, quality, regulatory, operations/manufacturing, research & development, etc)
• External regulatory bodies and industry groups

Essential responsibilities:

• Manage a product range that may include: medical devices, in vitro diagnostics, companion Diagnostics, Laboratory Developed Tests (LDTs)
• Develop and execute Regulatory Strategies with limited direction and/or guidance including: new product registrations, assessing changes to existing registrations, and maintaining registrations current for assigned products/geographies while ensuring that deadlines are met
• Execute and manage technical and scientific regulatory activities
• Review and approve marketing materials with limited oversight
• Maintain internal databases with latitude for process/business improvements
• Exercise some latitude in determining technical objectives of assignments
• Remain current on domestic and international regulations and standards in accordance with role and/or projects and internal procedures demonstrating a strong degree of knowledge in excel spreadsheet maintenance, use of outlook tools, sharepoint, SAP based systems, and other computer programs used for tracking and reference
• Provide RA leadership to assigned project teams
• Strong attention to detail, highly organized, and able to manage multiple projects simultaneously and able to lead projects/initiatives
• Participate in risk-benefit analysis for regulatory compliance
• Self-motivated and willingness to learn and proactively problem solve
• Ability to support and coordinate activities with global business partners in various time zones (including Asia Pacific (Australia) local time). He/She will manage/coordinate activities during evening hours as needed to support global initiatives
• Individual is recognized as an expert in work group and works effectively and collaboratively in a matrix organization
• Other duties as assigned

Qualifications/Education/Experience:

• A Bachelor´s degree in a relevant discipline
• 5-10 years of regulatory affairs experience in the medical device industry (including IVDs) preferred, will also consider experience in quality assurance, research and development and a higher education may compensate for years of experience. Experience with companion and oncology diagnostics highly valued.
• Demonstrated computer skills and strong written and verbal communications, and domestic and international experience preferred.
• US Medical Device application experience required. Primary author experience preferred: US-IDE, US-Q-Subs (Pre-Submissions), US-510k, US-PMA, CE Mark Class IIa, IIb, III, Canada Class III, IV. Experience Supporting New Product Introductions/Maintaining Existing Registration in Major Markets: APAC, Middle East, Latin America, experience preferred.
• Regulatory Affairs Certified (RAC) is desirable.

Skills/Knowledge/Cultural Fit:  

• Demonstrates strong written and verbal communication skills
• Fosters and enables innovation
• Displays dynamic leadership by being assertive and promoting ideas while building consensus
• Promotes teamwork by working collaboratively and closely with others, internally and externally
• Drives execution of action plans by addressing issues in a transparent and effective way.
• Displays agility and flexibility by quickly adjusting to new information in a fast-changing environment
• Strong collaboration, problem solving and analytical skills
• Professional and team-oriented interpersonal communication skills
• Ability to follow up with task owners to close out open items.
• Highly detail oriented with disciplined and effective time management, scheduling, and organizational skills
• Strong knowledge of and experience in applying data analysis and statistical techniques to product/process design and operational activities
• Must be analytical, flexible, innovative, and self-motivated
• Must have the flexibility in work arrangements to meet departmental goals
• Thrive on opportunity to excel and contribute