JOB TITLE: Senior Regulatory Affairs Specialist
DEPARTMENT: Regulatory Affairs
REPORTS TO: Vice President Clinical & Regulatory Strategy
Astute Medical, Inc. is an in-vitro diagnostics company dedicated to improving the diagnosis of high-risk medical conditions through the identification and validation of protein biomarkers that can serve as the basis for novel in-vitro diagnostic tests. To support the development and commercialization of its novel biomarker products, Astute Medical is seeking an energetic, self-motivated individual who can fill the role of Senior Regulatory Affairs Specialist.
This position will provide support to the Vice President, Clinical & Regulatory Strategy in the implementation of global regulatory strategies for marketed and development products. This individual will lead or support regulatory activities for internal and external programs and will work closely with cross-functional subject matter experts to ensure an effective partnership and execution of regulatory strategy, regulatory requirements, and the timely submission and approval of global regulatory filings.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Support management with development and implementation of departmental strategies and policies.
- Manage, coordinate and review regulatory submission/registration documentation for domestic and international product registrations, including the Independent determination of the necessary design documentation (including language/labeling requirements).
- Interpret regulations and provide regulatory guidance and strategy to cross functions project teams.
- Develop gap and impact assessments of changing global regulatory requirements (e.g., IVDR) and revise or drafts new documentation accordingly.
- Compile and maintain regulatory database of regulatory information, labeling and change requirements for international registrations to support market expansion.
- Regulatory lead on product/project teams, providing regulatory guidance with respect to product development and design control (changes and processes) and responsible for the preparation and review of associated deliverables.
- Independently research, prepare, and present on global regulatory topics to internal and external stakeholders. Contribute to the development and implementation of regulatory strategy to mitigate risks.
- Assure compliance with all applicable (domestic and international) regulations.
- Monitor regulatory trends and be able to apply learnings and provide guidance or strategy related to such trends.
- Create and support quality initiatives to maintain an environment of continuous improvement throughout the organization.
- Ensure compliance with Company’s Quality Management System and ensure that all individuals reporting to him/her comply with the Company’s Quality Management System.
- May mentor or lead other department staff.
- Other duties as assigned.
- Degree in a relevant field (BS/MS in engineering or science ideal) with 4-6 years relevant MD/IVD regulatory affairs experience (or equivalent combination education and/or work experience in another function with demonstrated transferable skills set dependent on the level of qualifications achieve.
- IVD, clinical diagnostic, CLIA or similar experience is preferred.
- General working knowledge of current and evolving state, federal (e.g., 21 CFR 820) and international procedures (e.g., IVDR, CMDR, and other worldwide regulatory regulations as appropriate and standards, e.g., ISO 13485, ISO 14971) relevant to the registration/clearance/approval and post-market surveillance of IVDs.
- Prior direct interactions with Health Authorities is desirable.
- Highly self-motivated; works on assignments of moderate scope where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
- Exceptional writing skills and verbal interpersonal skills to influence many diverse internal/external customer groups.
- High attention to detail, ability to work on multiple projects with tight deadlines and able to work independently.
- Ability to work cohesively with multi-disciplinary scientific working groups.
- Good organization, interpersonal and judgment skills to influence many diverse internal/external customer groups.
- Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio.
While performing the duties the employee is:
- Constantly required to reach computers and other office equipment
- Constantly required to view objects at close and distant ranges
- Frequently required to communicate with others
- Frequently required to sit
- Frequently required to stand
- Frequently required to use fine manipulation and simple grasping in order to handle laboratory equipment and to utilize the computer and other standard office equipment such as telephone, fax machines, copiers, etc.
- Frequently required to lift and transport items weighing up to 25 lbs.
- May occasionally be required to travel to audits, meetings, tradeshows
Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.
Employee frequently works in an office environment with a moderate amount of noise and activity. The work environment is fast-paced and demanding. Work weeks exceeding 40 hours are required as necessary.