Regulatory Affairs Specialist
Company: Coagusense Inc.
Posted on: January 15, 2022
This position is a member of the CoaguSense Regulatory team with
the responsibility of supporting and assisting in domestic and
international regulatory submissions, registrations and product
updates for CoaguSense products. This team member will also be
involved with the planning and implementation of IVDR requirements
for international approval of products.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Work closely and under the direct supervision of the Manager,
Regulatory Affairs to develop and maintain regulatory processes and
SOPs to ensure compliance with the latest applicable domestic and
international regulatory requirements;
Assist in the compilation, preparation, and review of domestic and
international regulatory submissions to authorities;
Keep abreast of new, proposed or revised domestic and international
regulations with the ability to determine the impact to the company
Assist 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
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
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
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.
A minimum of 3 to 5 years of experience in the medical device
industry, preferably with experience in IVD products. Exposure to
MDR and/or IVDR regulatory requirements a plus.
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.
Keywords: Coagusense Inc., Fremont , Regulatory Affairs Specialist, Other , Fremont, California
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