Theradaptive is revolutionizing the field of targeted therapeutic delivery with a pipeline of best-in-class products that address multiple global markets. Theradaptive is performing cutting edge science in regenerative medicine, working at the interface of Biology and tissue repair.

Our lead therapeutics are in the following indications:

• Spinal Fusion
• Trauma Repair
• Dental and Facial Bone Repair

We are an innovative, fast-paced team that is advancing a diverse array of cutting-edge translational research projects. At Theradaptive, you will experience the challenge and satisfaction of the therapeutic product development process firsthand, bridging both Biologics and Devices. Transform your career and join the Theradaptive team today!

POSITION SUMMARY:

We are seeking a proactive and independent Regulatory Affairs Associate with experience in regulatory filings and clinical trials with Class III medical devices. The Regulatory Affairs Associate’s primary responsibility will be the preparation of US FDA pre-submissions and submissions with support from the Theradaptive team. The individual may be based in the Maryland/DC Beltway area but we will consider remote work.  This position will interact with all parts of the organization including Research and Development, Analytical Development, Regulatory and Quality. Knowledge of combination devices is a plus.

Our ideal candidate will be highly motivated, detail-oriented, and have a proven ability to multi-task and pivot quickly based on project priorities. Excellent interpersonal skills and the ability to work well with internal and external staff at all levels is an important skill set needed to succeed in this role.

If you are driven to contribute in a highly dynamic environment, we encourage you to apply now!

RESPONSIBILITIES:

• Preparation of Pre-Submissions, IDEs and supplements to support Phase 1-3 clinical trials. This may include writing and compiling preclinical, clinical, and administrative sections of FDA filings for Combination Products.
• Preparation of PMA’s
• Experience in CTD format is a plus.
• Supports IDE lifecycle and maintenance activities (e.g., protocol amendments, clinical/preclinical information amendments, annual reports, DSUR’s, expedited safety reports, proprietary name requests, Clinical Study Plans & Protocols, responses to questions/information requests from health authorities) and assists in the preparation of briefing documents for milestone development meetings with regulatory agencies.
• Supports the preparation of PMA’s and international marketing applications
• Provides strategic input on the US and global regulatory strategy
• Provides regulatory support for clinical and preclinical drug/device development activities (e.g., reviews clinical trial documents including clinical protocols, Clinical Report Forms and study reports, Investigator Brochures, Informed Consent Forms, nonclinical protocols and reports, reviews and approves clinical development plans, clinical trial material manufacturing plans and labeling, and other essential documents related to clinical trials).
• In charge of the maintenance and compliance of Clinicaltrials.gov registrations.
• Applies knowledge of key guidance documents, regulations, or directives and effectively communicates any impact on product development programs and regulatory filings.
• Coordinates with cross-functional teams and interfaces with contractors, vendors, and consultants to define requirements for regulatory submissions.
• Liaises with other Regulatory Affairs functions (QA, Regulatory CMC, Operations/Documentation, and Compliance) to develop and manage timelines for the preparation of assigned regulatory filings.

QUALIFICATIONS:

• Bachelor’s degree (B.A. /B.S.) in Biology, Chemistry, Biochemistry, or related discipline
• 3+ years of direct experience in Regulatory/Clinical Affairs for combination products or medical devices.
• Must have experience in preparing FDA pre-submissions and IDEs
• IND experience a plus
• Knowledge of FDA and ICH guidelines for drug development as well as regulatory requirements for clinical trials, investigational drugs, and marketing applications
• Strong technical writing ability
• Knowledge of Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), and Good Manufacturing Practices (GMPs)
• Proficiency in Microsoft Office (Word, Excel, Outlook)

PHYSICAL DEMANDS:

• Ability to work in office setting
• Ability to travel to clinical sites and partner sites (domestic and international)

POSITION LOCATION:

• Preferred location is in Frederick, Maryland at the Theradaptive Laboratories but will consider remote work. Travel, including international travel, may be required 25% to 35% of the time for at least the first year.

DEPARTMENT:

• Clinical and Regulatory Affairs

https://www.theradaptive.com

Theradaptive is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, ethnic or national origin, ancestry, pregnancy (including childbirth or related condition), citizenship, familial status, mental or physical disability, veteran status, genetic information, other non-disqualifying disability, or any other characteristic protected by law.