Regulatory Affairs Associate - Coyote Technical & Executive Sourcing
Newport, SC
About the Job
REGULATORY AFFAIRS SPECIALIST
This is the optimal opportunity for a mid-level associate who is a driven, critical thinker who wants to take their career to the next level and help develop the foundation of a growing regulatory department.
The Regulatory Affairs Associate has responsibilities for pre market compliance with US and international medical device regulations for GMP exempt/non-exempt, sterile/non-sterile Class I & II medical devices as well as compliance with anti-corruption/anti-bribery (e.g. Sunshine Law) regulations.
ESSENTIAL JOB DUTIES
This is the optimal opportunity for a mid-level associate who is a driven, critical thinker who wants to take their career to the next level and help develop the foundation of a growing regulatory department.
The Regulatory Affairs Associate has responsibilities for pre market compliance with US and international medical device regulations for GMP exempt/non-exempt, sterile/non-sterile Class I & II medical devices as well as compliance with anti-corruption/anti-bribery (e.g. Sunshine Law) regulations.
ESSENTIAL JOB DUTIES
- Subject Matter Expert for all regulatory documentation (510(K)s, Letter To File) relating to the current and future Class I and II device product portfolios
- Maintains change control system, device registrations and device listings
- interacts effectively with internal and global functional business units in order to facilitate device claim support requirements and documentation for new submissions/device changes to maintain FDA regulatory compliance
- Participates on cross-functional teams as the regulatory representative for new product development /product changes
- Documents control system including reviewing, coordinating and approving quality documents, product/process changes, SOPs, advertising and promotional materials, labeling and product development reports
- Ensures compliance with all applicable company policies and procedures, local, state and federal laws and regulations including, data privacy (e.g., HIPAA data privacy), anti-corruption/anti-bribery (e.g. Sunshine Law).
- Key Opinion Leader (KOL) management in accordance with the Sunshine Law
- Writes/revises departmental SOPs as required
- Bachelor’s Degree, degree in scientific field such as Biochemistry, Medical Technology, Engineering, Chemistry, Biology preferred
- RAC certification a plus
- Highly analytical
- Excellent organizational and project management skills with strong attention to detail
- Working knowledge of FDA device Class I & II requirements and terminologies
- Strong skills and knowledge of corporate software tools -- Microsoft Office Suite including Word, Excel, Power Point
- 5 years of industry experience in Regulatory Affairs, preparing and filing submissions such as 510(k)’s and letter to file, preparing and maintaining regulatory documentation such as DHF’s, risk management files, and maintaining FDA registrations and device listings in the medical device industry
- Experience working independently in a fast-paced environment with rapidly changing priorities
- Budget management experience
- Multi-task oriented and organized to work within numerous systems and functions
- Work cooperatively in a cross functional team environment
- Knowledge of current standards and guidance concerning corporate compliance and ethics programs such as: anti-kickback and false claims laws; laws and regulations governing off-label promotion and scientific exchange; and Affordable Care Act and impact on health care industry, preferred
Source : Coyote Technical & Executive Sourcing
