What are the responsibilities and job description for the Medical Device 501K Filing Specialist position at Synergy Bioscience?
Synergy Bioscience is a startup company that provides medicinal product development support and laboratory testing services to our partners in the pharmaceutical and medical device industries. In addition, we provide quality compliance consulting services to our partners in the pharmaceutical, medical devices, and biotechnology industries.
Our Mission is to support our clients expedite their product commercialization efforts by providing world class services in timely manner without compromising their business confidentiality.
Role:
510k Filing Specialist will be responsible for product submissions, periodic updates, and registrations to regulatory agencies. This individual will organize regulatory information, track/control submissions, review and advise on labeling for compliance. They will manage regulatory filings, review product changes for impact and research regulatory issues, as well as; provide guidance and advice to colleagues.
Responsibilities:
- Ensure compliance to 231 CRF 820, ISO 13485, MDD/MDR, MDSAP, other regulatory requirements, company policies, operating procedures, processes, and task assignment
- To develop and implement domestic and international strategies for regulatory approval of Class I and II medical devices
- Researches and advises company on country specific international product registration and compliance related requirements
- Responsible for submission, preparation and development of labeling, marketing or promotional materials, training on departmental policies and procedures, new FDA guidance documents, and FDA warning letters, competitor updates technical and labeling reviews of supporting documents for inclusion in regulatory filing
- Review and manage changes to existing products and SOPs to define the requirements for regulatory submissions
- All other duties as assigned
Qualifications:
- Bachelor’s degree
- 5 years in Medical Devices 510k filing experience and understanding of GMP work environment.
- Strong verbal communication and technical writing skills.
- Strong technical, research and problem-solving skills
Skills:
- Regulatory affairs, project management, 501K, medical device industry experience
- FDA Regulations
COMPENSATION:
- Excellent hourly rate based on experience.
TYPE:
- This is a contract for one year with possible extension.
Location:
- Dallas, Texas