Our client a leading Wisconsin based manufacturer of disposable product seeks a Regulatory Affairs Manager.
Job Purpose /Summary
The Regulatory Affairs Manager is responsible for the domestic and international regulatory compliance for the medical devices and personal protection equipment designed and/or manufactured by company. Involvement begins as new products or product modifications initiate the design process to provide early guidance concerning regulatory requirements. This is a key leadership position and will be expected to model and deploy the corporate mission, core values, and guiding principles.
Essential Duties & Accountabilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- This position is responsible to develop and implement procedures which ensure compliance to US and International regulations.
- Develop a new Enterprise labeling system and team for label development, approvals and archiving.
- Assist with the development and implementation of an International Registration process for obtaining/maintaining marketing authorizations worldwide.
- Conduct US and International regulatory assessments for new and modified products.
- Frequent International registration submissions.
- Occasional 510(k) submissions.
- Develop and maintain EU technical files and/or design dossiers.
- Participate on project development teams to provide early guidance, design control reviews, and Regulatory Strategy.
- Coordinate Certificates to Foreign Governments, Free Sales Certificates, Apostilles, and notarization.
- Review and approve labeling for domestic and international compliance including meeting US and EU UDI requirements.
- Approve all communications to trade publications, news media release, sales presentations and technical bulletins and analyze the support data for claims verification.
- Maintain regulatory data, GUDID, and FDA medical device listings.
- File MDR’s with FDA and assist Director with FDA interaction concerning recalls and/or inspections.
- Accountable for modeling and providing training of the company’s Mission, Vision, Values, Value Discipline and Behaviors
- Demonstrates and actively supports company Mission, Vision, Values, Value Discipline and Behaviors;
- Collaborates effectively across the company and actions are consistent with Behavior Expectations.
Knowledge / Skills
Education and/or Experience
- Bachelor’s degree preferably in Engineering, Physical Science, or a clinical field.
- Minimum of seven years’ experience in the following areas: Quality Management & Regulatory Affairs, QSR (21 CRF 820), medical device manufacturing and ISO/EC (MDD, CMDR, ISO 13485) requirements.
- Knowledge of FDA, CMDR, MDD/MDR, TGA, ANVISA, and JPAL Regulations of medical devices and Personal Protection Equipment.
- Knowledge of ISO 13485, ISO 14971 and MDSAP.
- Ability to investigate and decipher US and International regulations.
- Ability to make decisions, develop and execute regulatory strategy.
- Ability to develop and implement compliant processes where none currently exists.
- Ability to mentor and develop team members, including goal setting and performance reviews.
- Ability to lead and direct the work of others ensuring maintenance of a robust Regulatory Affairs department.
- Ability to develop and maintain reporting metrics for enterprise label copy development
- Ability to manage multiple projects and teams.
- Ability to identify and adapt to shifting priorities and competing demands
- Ability to motivate individuals to collaborate on team projects and produce results
- Excellent verbal and written communication skills
- RAPS Certification and/or ASQ certification in Auditing – Biomedical is strongly preferred.
- Thorough understanding of FDA UDI/GUDID requirements.
- Customs Export/Import knowledge.
- Understanding of International registration requirements.
- ISO 13485, ISO 14971 & MDSAP.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this Job, the employee is regularly required to sit; use hands to finger, handle, or feel and talk or hear. The employee is occasionally required to walk. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually very quiet.
If you have any additional questions, please do not hesitate to contact me.