Regulatory Compliance Specialist

Job Location

14 Arrow St, Cambridge, MA 02138, USA

Job Type

Full Time

Category

Business Development

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About the Role

Job Description:

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.

Key Responsibilities:

  • 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

Requirements

Ideal Candidate Profile:

  1. 4 year degree, preferably in a field related to regulatory compliance

  2. 5+ years of professional experience

  3. 2+ years of experience with regulatory compliance

  4. Experience in healthcare

  5. Excellent communication skills, both written and oral. Must be able to expertly and optimally deal with team members, external stakeholders, sites, etc.

  6. Excellent communication, organizational, and collaboration skills

  7. Strong decision making and prioritization skills

  8. Self-starter with bias toward results and business outcomes

  9. Exceptional ability to be a team player

  10. Excellent follow up with team members and external stakeholders

  11. Takes initiative to anticipate and solve problems

  12. Ability to connect the appropriate team members and external stakeholders when necessary

Minimum Qualifications:

  1. Team player

  2. Ability to think on their feet and outside of the box

  3. Ability to work in a fluid environment

  4. Able to deliver in a fast-paced environment

  5. The ability to deal with ambiguity

  6. Experience working with cross-functional stakeholders in a business environment

  7. This position will require some travel

Preferred Qualifications:

  1. Previous experience as a regulatory compliance specialist

  2. Proven track record of success in previous roles

  3. Experience in a start-up environment where goals are often ambitious, and the environment and trajectory evolves rapidly

  4. Confidence and experience presenting to all environments

*Replace 'Job Title' with your desired position

About the Company

Company Mission:

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.