Regulatory Affairs Sr. Specialist
Company: Coagusense Inc.
Posted on: May 3, 2021
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
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
- Participate in risk management activities including revisions
to current procedures and files according to the latest
- 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 companys Quality Manual. Must have a history of successful
- 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.
- 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
- Ability to recognize problems, recommend and implement
solutions. A logical and organized thought pattern is
- 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 Sr. Specialist, Other , Fremont, California
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