This position will provide strategic and operational leadership for global Regulatory Affairs; lead the overall regulatory strategy from planning to submissions and post market regulatory change management. This role oversees Regulatory (and potentially Quality operations) for ChromaCode’s overall product portfolio which include molecular diagnostics reagent kits and software for use on traditional real-time PCR instruments. The position will be responsible for global regulatory process with primary focus on U.S., Europe and resource-limited countries. They will work cross-functionally with R&D, operations, marketing and other departments and manage external consultants and CROs as needed.
We are looking for someone who can build a strong and effective team to support the global regulatory landscape; anticipate and lead the regulatory org to stay ahead of the rapidly growing global regulatory environments; guide the regulatory path and strategy on new product development; build strong working relationship with US FDA and global regulatory agencies and competent authorities; maintain regulatory intelligence; represent the company as an interface with US FDA and global regulatory agencies.
This position will report to the Chief Executive Officer.
Who we are:
We are a fast-growing life sciences tools company, passionate about increasing the performance of molecular diagnostics instruments to drive better decision-making. We are currently using our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19. You will join a team of highly talented people in a well-funded, exciting environment.
What you will be responsible for:
- Design and direct pre-market and post-market regulatory strategies and successfully manage complex issues which have significant impact on the business.
- Develop and implement regulatory strategies which enable the company to operate competitively while managing regulatory activities.
- Work with business teams to anticipate the impact of current and emerging trends, identify potential opportunities or threats.
- Ensure company practices are consistent with corporate regulatory risk posture.
- Represent company on industry committees and regulatory organizations.
- Manage communications with regulatory agencies in the EU, the U.S., and other global regulatory agencies for all geographic areas as needed.
- Initiate tactical, cross-functional and local process improvements to streamline organizational process improvement.
- Help the organization navigate the RUO, LDT, EUA and IVD product opportunities for COVID related applications from a regulatory perspective
- (Potentially, manage the Quality organization, depending on experience)
Your ideal qualifications:
- Bachelors or Masters degree with 10+ years of experience and 5+ years managing people.
- Broad Regulatory Affairs experience working with the US FDA and global regulatory agencies in the In Vitro Diagnostics Industry.
- Demonstrated track record of successful regulatory submissions.
- Experience leading a global organization with a strong track record of building and developing teams.
- Demonstrated knowledge and understanding of global regulations and guidelines governing the areas of in vitro diagnostic development.
- Experience in the development, registration and commercialization of clinical diagnostics products; experience in molecular diagnostics products is preferred.
- Ability to develop effective regulatory strategies and apply regulations to pre-market and post-market strategies.
- Understanding of CLIA processes for validating RUO products for lab-developed tests.
- Possesses a broad knowledge of surrounding areas including Quality Assurance, Manufacturing and Development.
- Act decisively and backup decisions/recommendations with specific references to regulatory guidance from appropriate government agency.
- Ability to help company navigate regulations and collaborate on risk assessments.
- Ability to adopt a systemic view of process improvement and to help facilitate process improvements that enable the company to navigate regulatory obligations with greatest efficiency
Personal Skills / Attributes:
- Leadership: has the ability to move others to action, including peers, superiors and subordinates. Demonstrate a positive, results-oriented style
- Communication: Ability to develop and articulate an effective flow of ideas and information that generates understanding and creates a climate in which others are informed and want to participate.
- Courage: Not afraid to stand up for his/her beliefs or voice an unpopular opinion. Willing to try new ways without fear of failure. Challenges the status quo.
- Planning and Analyzing Skills: Use an analytical approach; evaluate a situation from varying perspectives to create well-reasoned solutions.
- Interpersonal Skills: Able to foster excellent relationships and credibility quickly at all levels of the organization. An ability to create a partnership atmosphere with internal and external resources while achieving key operating objectives.
If interested, please email resume and cover letter describing your qualifications to: email@example.com
ChromaCode believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at firstname.lastname@example.org. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf