Regulatory Affairs Sr. Specialist
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
- 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 company’s 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.
- The ability to communicate articulately, in English, both verbally and in written materials is required.
- The candidate must be able to perform basic math functions.
- Ability to recognize problems, recommend and implement solutions. A logical and organized thought pattern is required.
- 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.
Learn more here
Job posted: 2021-03-13