Principal Regulatory Affairs Specialist
Why Join ACIST?
We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the ACIST team has the power to make a difference......every day!
The Principal Regulatory Affairs Specialist is responsible for the development and implementation of the regulatory strategy (as applied to project, process, and/or product) and partners with internal stakeholders (e.g., regions) to align on an optimized regulatory strategy in order to achieve business objectives. This individual will provide hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements/strategies and preparation of submissions, perform regulatory submission/approval activities for specific complex ACIST Medical Systems products, represent ACIST Regulatory with US and international regulators on submission reviews/approvals and ensure compliance with required regulations and established corporate standards, ensure that product approvals are properly maintained and product re-registrations are properly managed. This individual will exercise creativity/innovation with expectations of independent research and use of accepted regulatory practices in the execution of tasks.
Primary Duties and Responsibilities
- Define regulatory requirements necessary for regulatory approval of products.
- Independently complete regulatory assessments needed to support projects and provide direction to project teams on regulatory agency expectations and guidelines to support new product development and product modifications.
- Provide direction on application of external standards to project team.
- Develop and execute FDA, Notified Body, TGA, and Health Canada product submission strategies.
- Maintain regulatory documentation in accordance with departmental practices and quality system requirements.
- Support audits and participate in CAPAs, process improvements, and other special projects as needed.
- Work with the international regulatory team to develop, document, and communicate registration deliverables and strategies to the product development or project team.
Qualifications (Knowledge, Skills & Abilities):
- BA degree in Science or Engineering
- Minimum of 8 years of experience in Regulatory Affairs
- Minimum of 8 years medical device industry experience including strong 510(k) submission experience, EU CE Mark submissions, Health Canada submissions, and international market submissions.
- Strong working knowledge and experience with quality systems regulations and guidelines, ISO, GMP, Medical Device Directive (MDD)/Medical Device Regulations (MDR) and FDA regulatory requirements.
- Skill in determining alternatives that would correct a situation to comply with standards and regulations
- High level of planning and organizational skills
- Demonstrates ability to coordinate and work effectively with multiple stakeholders.
- Ensures timely, clear communications to internal stakeholders on project status and issues.
- Serves as role model and embraces corporate Values and Behaviors
- Demonstrates good organizational and time management skills, including the ability to work on multiple projects and adhere to timelines.
- Meets individual goals as defined in the annual objectives.
- Ability to support the business by communicating effectively, managing issues proactively, resolving conflicts and mitigating risks.
- Ability to work in a matrixed environment and influence internal partners to achieve desired business outcomes.
- Strong writing skills in the form of high quality regulatory submission documents.
- Commits to driving efficiency while maintaining quality.
- Drives superior results by taking initiative, planning and implementing projects, setting priorities and holding self and others accountable to meet commitments.
- Travel requirements are minimal. Travel about 2-3 times annually for 2-3 days duration each trip.
- RAC Certification.
- 10 years or greater of experience in medical device industry.
- 10 plus years working in Regulatory Affairs.
- Strong FDA, Health Canada, TGA, and EU submission experience.
- Demonstrated ability in project management skills in order to support multiple projects and execute regulatory deliverables per project timelines.
- Working knowledge of clinical trial strategy and study design, statistical methods, and data reporting.
- Working knowledge of quality system requirements, including design controls, risk management, and product development processes.
- High level of planning and organizational skills.
- Effective research and analytical skills.
- Requires intense concentration in order to accurately assess compliance to applicable regulations for medical device manufacturers and comparing them to processes, policies, procedures and other quality related documentation, which may involve point-by-point comparisons.
- The work is detail oriented, often with multiple priorities.
- The environment is deadline sensitive. Frequent high-pressure situations.