Location: Remote
Employment: Contract
We are now looking for a Legal & Compliance professional to be the point person for legal and compliance matters and procuring an optimum solution from legal counsel. This is a 6+month, exclusive contract position, reporting to our CEO.
Responsibilities:
- Direct and oversee compliance with all relevant healthcare and corporate regulations promulgated by the U.S. and international governmental bodies and regulatory authorities.
- Identify, including receiving internal communications, regarding matters of potential legal risk and/or consequence and, under the guidance of relevant legal counsel (our existing trusted relationships) and the company’s CEO and President, review each to determine the likelihood and extent of material risk and consequence, perform thorough investigation(s) into the matter if needed, and address and handle each as appropriate based on risk and consequence, to a closed status (minimized remaining risk / consequence), all consistent with the highest ethical standards.
- For each legal matter reviewed and addressed, catalog the final determination of each matter as company policy and part of our legal policy manual.
- Apply these policies intelligently and effectively towards the purpose of the company and its greatest good. Ensure these policies are complied with company wide, including performing regular internal reviews or audits, and implementing intelligent controls to ensure the company is compliant with applicable laws and regulations.
- For each matter, proactively report the status during its respective handling and upon completion to the company’s CEO and President.
- Execute all the above in a way that speeds production, reduces and eliminates red tape, and gets the show on the road. Your efforts should accelerate innovation and reduce friction, not slow or stop positive contributors to the company’s success.
Requirements:
- Must have extensive experience and in-depth industry hands-on knowledge of regulations for the medical device industry, as well as general corporate regulatory matters, in terms of planning, response, strategy and execution.
- Calm demeanor.
- Logical and strategic thinking.
- Uncompromising ethical standards.
- Critical-thinker and problem-solver.
- Entrepreneurial minded.
- Results oriented.
- Elegant, outside the box thinking.
- Committed to the company winning in the market based on taking into account ideas and recommendations from counsel and other trusted advisors versus a rigid insistent on being personally correct.
- Razor sharp thinking. Ability to differentiate between fine nuances and hold or call many such nuances in mind to discuss, and drive to and arrive at a solution.
- Evaluate, prioritize, and act based on risks and consequences.
- Have or develop knowledge and expertise in matters related to healthcare law and regulations (fraud, anti-kickback statutes, Stark Law, etc. following compliance guideline programs from the OIG of HHS) SEC / securities, FDA, OSHA, medical billing and general business compliance that any or many types of businesses must regulate.
- Figure out how to get to YES, with zero compromise on applicable legal and ethical standards.
- Legal experience, and/or business management experience with legal aspects, is a must.
- Strong interpersonal and communication skills
- In addition to legal experience, and/or business management experience with legal aspects, real world attained skills, attitude, experience, and results are what is needed. College degree is not required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit for extended periods of time and use hands to operate a computer and other office equipment. The employee is frequently required to reach with hands and arms, talk, and hear. Specific vision abilities required by this job include close vision and the ability to adjust focus.
We are an equal opportunity employer. Qualified Applicants are considered for positions and are evaluated without regard to mental or physical disability, race, color, religion, gender, national origin, age, genetic information, military or veteran status, sexual orientation, marital status, or any other classification protected under applicable Federal, State or Local law.