The RA Director provides company-wide regulatory direction for product development and guidance to develop rapid successful strategies for market approval(s) aligned with business objective(s) and regulatory compliance. Work is performed without significant direction and he/she is effective in exercising significant latitude in meeting the company objectives and creating departmental objectives. The RA Director is considered a key opinion leader within the organization. The Director, Regulatory Affairs ensures compliance with company standards and the applicable US and international regulations in which the company does business. The RA Director will also develop and advance organizational policies and procedures, while also anticipating regulatory obstacles and risks/emerging issues that may impact current or future projects while developing the corresponding solutions. The RA Director is effective in collaborating within the organization without direct authority and provides leadership by communicating, executing, and providing guidance to team members towards achieving the department/corporate objectives.
The RA Director, either directly /or via a team member (RA Manager/RA Associate) 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. The RA Director will combine knowledge of scientific, engineering, regulatory, and business to lead and support the development of products that meet the Regulatory requirements in the intended markets (product range: medical devices/in-vitro diagnostics, companion diagnostics, laboratory developed tests (LDTs). The individual will execute tasks and play a consultative role by partnering across internal business functions. The individual will also lead discussions/negotiations with Regulatory Bodies. The Director may have direct reports which will require mentoring and development.
- Internal departments needing regulatory services and support (marketing, regional management, customer service, quality, regulatory, operations/manufacturing, research & development, etc)
- External regulatory bodies and industry groups
- Regulatory Strategy Development (incorporating regulatory considerations into company objectives for product entry and exit)
- Able to effectively communicate in writing, includes ability to work with cross functional groups that may include scientist, engineers, clinicians and translating their works into regulatory content for regulatory bodies
- Lead and/or represent the organization at external events: consultations/negotiations with regulatory bodies, trade associations, and at industry groups/meetings
- Execute new product registrations, assessing changes to existing registrations, and maintaining registrations current for assigned products/geographies, and review/approval of marketing material
- Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle and develop the corresponding solutions with other members
- Create short and long term plans for objectives created by management and within the regulatory department
- Responsible for tracking personal and team performance to company objectives and effectively communicate the status of projects proactively and upon request, and Forecasts future team/departmental needs
- Self-motivated and able to motivate team members and a willingness to learn and proactively problem solve
- Recruit, develop, and mentor regulatory professionals
- Demonstrate 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.
- Maintain records and documents for established systems that support regulatory activities and requirements.
- Strong attention to detail, highly organized, and able to manage multiple projects simultaneously
- Lead projects/initiatives directly or by guiding team members
- Develop and remain current on applicable internal procedures/process(s) and applicable regulations (US and INTL)
- Lead and collaborate with organization members to support audits/inspections (internal/external) and represent regulatory affairs in product recalls and recall communication process in accordance with company procedures
- Develop and advance the organization’s policies, process, and SOPs
- Conduct regulatory due diligence
- Develop solutions to address issues collaboratively with other members of management
- Develop, communicate, and build consensus for operating goals and issue resolution
- Interface with various levels of management on significant matters, often requiring the coordination of activities across sites
- Ability to support and coordinate activities with global business partners in various time zones (including Asia Pacific (Australia) local time). The Director may manage/coordinate activities during evening hours as needed to support global initiatives
- Understanding compliance to Corporate and Regulatory procedures/ requirements and goals
- Other duties as assigned
- A Bachelor´s degree in a relevant discipline
- 10+ years of regulatory affairs experience in the medical device industry (including IVDs) preferred and will also consider 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: IDE, Q-Subs, 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.
- Experience developing and managing regulatory affairs teams
- Regulatory Affairs Certified (RAC) is desirable
- 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