485 E Half Day Rd., Suite 320
Buffalo Grove, IL 60089
Job Title: Regulatory Affairs Specialist
Location – Buffalo Grove, IL
We are seeking an experienced regulatory affairs specialist to participate in and guide teams involved in the production, marketing, and distribution of Class I and II electromechanical devices and disposables to verify that all functions are operating according to regulations. The Regulatory Specialist must keep abreast of legislative developments in the countries or regions in which products are distributed, and advise and strategize with management, keeping them informed of the implications of regulatory developments and advising on methods to execute plans as needed.
- Monitor applicable regulatory requirements; assure compliance with internal procedures and external standards
- Compile and maintain 510(k), Technical File and other regulatory files, in a format consistent with requirements. Complete memos to file assessing changes.
- Develop regulatory project plans, and align with global, regional and local marketing strategies.
- Prepare, review, and approve labelling and SOP’s
- Complete product and facility registrations, license extensions and amendments, renewals according to agreed timeline, and ensure approvals in a timely manner for regions in which Ameda distributes.
- Maintenance of regulatory databases
- Provide front and back room assistance for audits.
- Provide support for responding to audits.
- Maintain Health Canada regulatory licenses.
- Maintain Certificates of Conformance for the EU.
- Providing regulatory advice and support for new product development.
- Unique Device Identifier (UDI) implementation and maintenance
- Min 5-8 years regulatory experience in medical device industry with products marketed in the US, EU, and Canada.
- BS degree in a technical discipline.
- Experience filing 510K and other submission packages.
- Proficient in 21 CFR 820 and the Medical Device Directive, and Canadian Medical Device Regulations.
- Working knowledge of FDA and international regulations.
- Working knowledge of quality management systems.
- Experience dealing with notified bodies.
- Working knowledge of 13485 and CE mark requirements.
- Working knowledge of MDR Reporting.
- Experience conducting internal audits and writing audit respons
- Sound basis of Regulatory and scientific knowledge
- Attention to detail and commitment to
- Ability to manage complex projects and timelines in a matrix team environment
- Written and verbal communication and presentation skills
- Ability to independently identify compliance risks and escalate when necessary
- Thorough knowledge of applicable procedures, specifications, regulations and standards.
- Organized in self, work and environment
- Able to work in a matrix and cross-cultural environment
- PC skills including Word, Excel, and interest and ability to learn other programs as required
- Excellent interpersonal skills.
- Proficient in technical writing and oral communication.
- Experience researching regulatory requirements.
- Ability to plan, execute, and complete projects in timeframes allotted.
- Ability to work independently.
Required Behavioral Competencies
- Quality Orientation – Accomplishes tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checks processes and tasks; is watchful over a period of time.
- Builds Strategic Working Relationships – Develops and uses collaborative relationships to facilitate the accomplishment of work goals.
- Facilitates Change – Encourages others to seek opportunities for different and innovative approaches to addressing problems and opportunities; facilitating the implementation and acceptance of change within the workplace.
- Manages Work – Effectively manages one’s time and resources to ensure that work is completed efficiently.
- Decision Making – Identifies and understands issues, problems, and opportunities; compares data from different sources to draw conclusions; use effective approaches for choosing a course of action or developing appropriate solutions; take action that is consistent with available facts, constraints, and probable consequences.
- Initiates Action – Takes prompt action to accomplish objectives; takes action to achieve goals beyond what is required; is proactive.
- Contributes to Team Success – Actively participates as a member of a team to move the team toward the completion of goals.