About the Role
We are seeking a results-driven regulatory compliance specialist to implement and develop regulatory compliance strategies for our Clinical Business Development team initiatives. You will be responsible for reviewing documentation and procedures, collaborating with internal and external stakeholders on compliance-related issues, and performing compliance audits.
To ensure success as a regulatory compliance specialist, you should exhibit extensive experience in regulatory compliance coordination and in-depth industry knowledge. An accomplished regulatory compliance specialist will be someone who can facilitate regulatory compliance to help our company develop and maintain an excellent reputation.
Reviewing documentation, processes and practices
Developing and enacting regulatory compliance strategies
Coordinating regulatory compliance procedures across organizational structures
Providing training in compliance practices and procedures
Monitoring compliance and facilitating interventions to manage risks
Performing compliance audits and compiling reports
Documenting compliance related processes and maintaining records
Keeping abreast of regulatory changes and developments in the regulatory environment
Researching industry compliance regulations and policies
Evaluating internal operational and procedural compliance
Analyzing and updating existing compliance policies and related documentation
Communicating compliance policies and guidelines to management and designated departments
Developing and executing new compliance policies and procedures as necessary
Applying for compliance certification and regulatory approval
Developing and maintaining a compliance recordkeeping system
Maintaining communication with compliance regulators and following up on applications
Ideal Candidate Profile:
4 year degree, preferably in a field related to regulatory compliance
5+ years of professional experience
2+ years of experience with regulatory compliance
Experience in healthcare
Excellent communication skills, both written and oral. Must be able to expertly and optimally deal with team members, external stakeholders, sites, etc.
Excellent communication, organizational, and collaboration skills
Strong decision making and prioritization skills
Self-starter with bias toward results and business outcomes
Exceptional ability to be a team player
Excellent follow up with team members and external stakeholders
Takes initiative to anticipate and solve problems
Ability to connect the appropriate team members and external stakeholders when necessary
Ability to think on their feet and outside of the box
Ability to work in a fluid environment
Able to deliver in a fast-paced environment
The ability to deal with ambiguity
Experience working with cross-functional stakeholders in a business environment
This position will require some travel
Previous experience as a regulatory compliance specialist
Proven track record of success in previous roles
Experience in a start-up environment where goals are often ambitious, and the environment and trajectory evolves rapidly
Confidence and experience presenting to all environments
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About the Company
Iterative Scopes is an early-growth stage startup on a mission to revolutionize the treatment of gastrointestinal diseases with computer vision. We are backed by leading venture firms, top pharmaceutical companies as well as category defining healthcare leaders including; Obvious Ventures, Eli Lilly, Janssen Pharmaceuticals, Founders of Flatiron Health, Livongo, Path.AI, PAIGE, WHOOP!, Okta, and Recursion Pharmaceuticals.
Iterative Scopes is a venture backed company established by Jonathan Ng, MD a second time founder. The scientific advisory board includes world-class gastroenterologists and leading MIT computer vision and machine learning researchers and faculty.
Recruitment & Staffing:
Agencies - Iterative Scopes does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Iterative Scopes or its employees is strictly prohibited unless contacted directly by Iterative Scopes' internal operations team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Iterative Scopes, and Iterative Scopes will not owe any referral or other fees with respect thereto.