GeneCoda has been retained to recruit candidates to be based in RTP, NC for the role of (Senior) Regulatory Specialist.
About Our Client:
Our client is deeply committed to medical device companies and has a successful track record at driving intrinsic client business value and creating operational excellence through developing and delivering quality systems, regulatory strategies, and submissions. Differentiating our client from other consulting firms is their dynamic environment, devotion to their people and focus on the people, processes, and technology leveraged to improve both their client’s business and teams.
Our client’s mission is to help transform medical device companies around the world by successfully integrating their core values of accountability, integrity, and knowledge with their regulatory, quality, business and technology expertise. Our client’s core values and capabilities evolve around a passionate focus for the success of their client’s products and the people behind those products. For our client, this includes the success of their employees and the employees of their clients.
Supporting their growth, our client is seeking an experienced and dynamic Regulatory and Quality Assurance Consultant who has a strong interest accelerating their professional growth in a fast-paced environment and who passionately cares about its team members and its clients. This person will directly support the executive team and more junior staff in the creation of client deliverables. This person will be a passionate “doer” who has a voracious appetite for learning, working with new products and takes pride in team success.
The successful candidate will be able to demonstrate experience interacting with FDA inspectors and product reviewers, understand the importance and purpose of regulatory strategies and has experience successfully addressing a wide range of regulatory and quality assurance issues. The candidate will also be able to express an understanding of and facility for team building, not only while consulting with clients but also while working internally.
The successful candidate is looking for an unparalleled opportunity to grow and advance their professional growth within a business culture of a company with a mission, core values, strong capabilities, a variety of client engagements, and a collaborative environment that delivers value. Apply for this opportunity only if you want to embark on a fast-paced, dynamic, and rewarding career path where no two days are ever the same and the culture is focused on providing you with the tools and opportunities to develop and advance your consulting and industry expertise.
Assisting with or when appropriate taking responsibility for the development, authoring or implementation of
- Regulatory Roadmaps and Assessments
- Regulatory or Quality Assurance Gap Assessments
- Quality Management Systems (QMS) or QMS components in compliance with US FDA and Global Quality System Regulations (e.g. 21 CFR Part 820, ISO 13485)
- Risk files and risk assessments
- Documentation, protocols and data analysis for Usability Studies or Human Factors and Human Engineering Studies
- Internal and supplier audits for compliance with Medical Device Quality System Regulations
- Verification and Validation activities for medical devices
- Medical Device or Combination Product submissions for clearance or approval for US or global medical device markets (e.g. 510(k), PMA, CE Mark)
- Directly working with clients in the creation and delivery of deliverables
Education: Minimum of a Bachelor’s Degree with a preference for a degree in Biomedical Engineering.
- 4 - 5 years of experience working for a medical device company or consulting firm in a regulatory affairs capacity.
- Experience with hosting FDA audits and communicating with the FDA (CDRH) medical device product reviewers.
Core Competencies and Skills:
- Deep interest in accelerating professional growth in a fast pace and dynamic environment
- Experience with cultivating interpersonal working relationships for executing work in a collaborative environment.
- Ability to work in a growth organization to support both executives and less experienced staff in the execution of deliverables.
- Interest in and ability to move from one diverse project or task to another with agility.
- A proactive and efficient learner who also understands the value of the client’s time.
- Ability to understand and respond appropriately to established priorities or client urgencies.
- Excellent analytical, research, and problem-solving
- Effective verbal and writing skills with experience successfully conveying complex concepts to diverse audiences.
- Strong organizational skills
- Ability to travel in the US and abroad.
GeneCoda refers qualified applicants for all jobs without regard to race, color, religion, creed, age, sex, disability, marital status, national origin, pregnancy, family medical history or genetic information, sexual orientation or preference, Vietnam Era Veteran status or other protected military status or any other status protected by federal, state or local law.