Essential Duties and Responsibilities
- Prepare and submit documents, including IDEs, PMAs, and Design Dossiers to domestic and international regulatory authorities to obtain marketing licenses. Interface with regulatory agencies to acquire marketing licenses (FDA approval orders, CE mark) for company products.
- Advise company management on domestic and international regulatory strategies and tactics for obtaining marketing approvals. Meet regularly with department heads to keep informed and to provide direction.
- Maintain awareness of domestic and international regulations that could affect company business, and implement appropriate company policies to achieve and maintain compliance.
- Establish and implement Regulatory Affairs procedures.
- Participate in the establishment and implementation of company policies and procedures, including those not limited to regulatory or quality.
- Manage department budget and associated spending and forecasting.
- Manage the compliance and documentation functions.
- Interface with regulatory agencies during inspections/audits of company facilities, OEM facilities and clinical sites, as needed.
- Supervise the internal audit process.
- Participate in Design Control meetings with Product Development to provide regulatory input.
- Review and approve all SynCardia product labelling (including website content, manuals, guides, presentations) and regulatory reporting documents (including Annual Reports to FDA and Notified Body).
- Manage post-market surveillance activities and associated reports.
Responsibility and Authority Affecting Quality
- Initiate action to prevent the occurrence of nonconformities relating to the product, process and Quality System.
- Identify and record any problems relating to the product, process and quality system.
- Initiate, recommend or provide solutions through designated channels.
- Verify the implementation of solutions.
Skills and abilities (required for the job)
- Excellent communication skills
- Excellent writing skills
- Strong organizational skills
- Detail oriented
- Ability to handle multiple tasks simultaneously
- A team player
Education, experience and training (required for the job)
Bachelors or Graduate Degree in Computer Science, MIS, Business, or equivalent experience.
Minimum of five years of US and OUS regulatory affairs, clinical affairs and quality experience with Class II and/or Class III medical device companies, or equivalent. Implantable device experience preferred.
Scientifically trained and technically competent in all areas relating to Regulatory Affairs, for Class II and/or Class III medical devices.
Proficient in the use of modern management and communication tools.
1. Work Station Area: Office
2. Special Factors in the Work Area: None
The working environment is indoors and is seasonally heated and cooled with minimal noise levels.
The position requires considerable sitting, typing and the ability to move objects of less than 25 pounds.
The position requires the ability to communicate in person, telephonically and via email.