Report this job

---

What is the problem? *

Incorrect company
Incorrect location
Job is expired
Job may be a scam
Other

Roles and Responsibilities:

• Lead and coordinate gap analysis and implementation of new or updated standards, guidance's, and regulations.
• Represent RA and demonstrate leadership in Audits, CAPAs, and related compliance activities.
• Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory strategies to partners.
• Proactively lead regulatory efforts required to align with new regulations and requirements; i.e., EU MDR, MDSAP.
• Review protocols and reports to assure collection of appropriate data for regulatory submissions and regulatory compliance.
• Write and update standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards to support continuous product development and compliance efforts.
• Work cross-functionally and lead cross-functional teams to in preparation of product submissions
• Represent company in relevant external trade organizations.
• Remain current on standards and regulations affecting products and keep the relevant team and supervisors informed about potential impact.
• Identify ways to improve the efficiency of current work process and execute them.

Requirements:

• Read, analyze, and interpret, and review scientific, technical, and regulatory literature and documents.
• Effectively communicate information to peers and all levels of management.
• Translate regulations and guidelines into terms that other functions can understand and apply.
• Define problems, collect data, establish facts, and draw valid conclusions; communicate the conclusions both verbally and in writing to a variety of audiences.
• Solve practical problems based on a variety of concrete variables in situations where only limited standardization exists.
• Excellent writing skills; both formatting as well as the development of a clear logic trail to develop conclusions based on an understanding of factual evidence.
• Strong influencing skills. Establishes process and provides expertise for a specific area.
• May supervise a staff of associates and managers.

Education:

• Bachelor's Degree, preferably Master's Degree in life sciences.

Qualifications:

• 7-8 years of strong Regulatory Affairs/Compliance experience in medical device company.
• Expertise and sound understanding of design control processes; FDA, global regulations and standards, and Quality Systems.
• Working knowledge of medical device stand-alone software, device interoperability, IEC 62304 software development lifecycle, and IEC 60601
• Ability to manage multiple projects, meet deadlines, and prioritize/organize complex information.
• Excellent interpersonal, communication and analytical skills.
• Knowledge of software and instrument design regulations and standards.