For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
The Senior MedTech Regulatory Consultant position is responsible for supporting or independently executing and managing MedTech regulatory affairs projects and providing consulting services to clients, as needed, including the development and maintenance of regulatory submissions and compliance activities. This role will serve as a subject matter expert (SME) within multiple areas of the device and diagnostics industry based on previous experience and applicable knowledge. This position will also prepare and submit regulatory documents, track submissions, and ensure compliance with regulatory requirements.
Essential Functions
- Represent ProPharma as a subject matter expert (SME) within assigned client projects. Serve as primary contact for clients related to project execution.
- Prepare and submit regulatory documents, including IDE’s, PMA’s, 510(k)s, and other regulatory submissions, in compliance with FDA and other relevant regulatory requirements.
- Track submissions and responses to regulatory agencies and communicate with regulatory agencies regarding submissions and queries.
- Prepare and maintain regulatory files, including electronic and paper files, in compliance with regulatory requirements.
- Support the development of regulatory strategies, in collaboration with cross functional teams, including clinical operations and quality assurance.
- Participate in meetings with FDA on behalf of Sponsors.
- Review labeling and promotional material for compliance with regulatory requirements and provide guidance to cross functional teams.
- Participate in the preparation and review of clinical protocols, reports, and other regulatory related documents.
- Keep up to date with regulatory guidelines and requirements and ensure that submissions and compliance activities are aligned with industry best practices.
- Support the maintenance of regulatory databases, tracking systems, and other tools used for regulatory submissions and compliance activities.
- Support the preparation and review of responses to regulatory agency queries and deficiency letters.
- Other duties as assigned.
Necessary Skills and Abilities
- Good knowledge of FDA regulations and other relevant regulatory requirements.
- Strong attention to detail, and the ability to manage multiple tasks and priorities effectively.
- Excellent communication and interpersonal skills, and the ability to work effectively in a team environment.
- Strong problem-solving skills, and the ability to analyze and interpret complex information. Proficient in Microsoft Office suite of products.
Educational Requirements
- Bachelor’s degree in a relevant field, such as life sciences or regulatory affairs.
- Advance degree is preferred.
Experience Requirements
- 5+ years of experience in regulatory affairs in the biotechnology or medical device industry.
- Experience with regulatory databases and tracking systems is preferred.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
- ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
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