Regulatory Affairs Sr. Specialist

SUMMARY

This position is an important member of the CoaguSense Regulatory team with responsibility for developing and driving the timely preparation of world-wide regulatory submissions and product updates for

our products. This team member will serve as a regulatory core team lead and provide ongoing regulatory guidance to project teams and the company.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Develop and maintain regulatory processes and SOPs to ensure compliance with the latest applicable

domestic and international regulatory requirements;

• Provide regulatory input to product lifecycle planning for current and new products in development;
• Assist in the development of multi-country regulatory strategy, and update strategies based upon regulatory changes. Determine submission and approval requirements as applicable;
• Compile, prepare, review and submit domestic and international regulatory submissions to authorities, and interact with regulatory authorities to answer questions in a timely manner;
• Keep abreast of new, proposed or revised domestic and international regulations with the ability to determine the impact to the company and products;
• Lead the company in the implementation of compliance requirements for IVDR, including revision to internal procedures, preparation for clinical trials and Post Market Surveillance;
• Prepare and/or review analytical and clinical protocols to assure collection of appropriate data for regulatory submissions;
• Participate in risk management activities including revisions to current procedures and files according to the latest standard;
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop

solutions with other members of regulatory and related teams

QUALIFICATIONS

• Must have a working understanding and knowledge of both U.S. and international regulations, including FDA Quality System Regulations (21 CFR Part 820), ISO 13485 Medical devices Quality Management Systems, In Vitro Diagnostic Directive (98/79/EC) and all relevant domestic and international standards as outlined in the companys Quality Manual. Must have a history of successful Regulatory submissions.
• Demonstrated ability to perform detail oriented work with a high degree of accuracy and recall. Requires strong written, oral, interpersonal, group, and communication skills. Effective organization and planning skills.
• Must be able to follow established policies and procedures, revise or create new procedures, and comply with regulatory requirements.
• Computer skills are required, with experience using Microsoft Office: Word, Excel, and PowerPoint.
• Demonstrated ability to deal with unresolved situations, frequent changes, delays or unexpected events.
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above and below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

• Prefer a Bachelor's Degree in the natural or biological sciences, or equivalent. Will consider years of work related experience in lieu of degree.
• 3 to 5 years of experience in a medical device company, with direct regulatory affairs experience.

LANGUAGE SKILLS

• The ability to communicate articulately, in English, both verbally and in written materials is required.

MATHEMATICAL SKILLS

• The candidate must be able to perform basic math functions.

REASONING ABILITY

• Ability to recognize problems, recommend and implement solutions. A logical and organized thought pattern is required.

WORK ENVIRONMENT

• The individual must work well in a rapid paced environment. The position requires the candidate to be flexible, and have the ability to juggle many projects at a time.