search jobs

Director of Regulatory Affairs | Orthopedics | Virginia

Norfolk, VA 23508 US

Industry: Regulatory Affairs Job Number: 2398

Job Description

Director of Regulatory Affairs | Orthopedics | Virginia

This is a chance to join a true startup and play a major role in bringing disruptive biologics products to market! As the Director of Regulatory Affairs for this orthopedic technology startup, you will be the guiding hand in bringing these innovative medical devices through the 510k process.

In this role, you will be the primary point of contact with the FDA for all 510(k) activities. While this young company is already commercial with their first product, there is a robust pipeline of new technologies that will need to be guided through the regulatory process. Because this is such a small and rapidly growing company, your ability to adapt to new challenges as they arise will be critical to yours and the company’s success. The teams here are transparent and work effectively together, so you should already have a collaborative attitude to work here. Expect to build your own team after establishing the groundwork in the first few months. There will be a blend of strategic management and getting in and doing the job yourself – expect to be a player coach in all aspects of the job. Additionally, there will be some crossover with the clinical side of the business, especially for trial development and site selection. If you have experience overlapping with the clinical side of the business, that is a huge advantage here.

To succeed in this role, you have an expert level knowledge of medical device regulatory processes and the 510(k) submission process. Ideally, we would love to see your previous experience with innovative orthopedic, sports medicine, or biologics products and how you helped win regulatory approval for them. Your product development knowledge will also be a major bonus, as well as your knowledge of post-market support for new products. If you’ve previously interfaced heavily with clinical affairs, you would be a major value add for the company as well. For the right individual, we’re offering a competitive compensation package with a strong equity offering as well. We truly want you to believe in our vision and products and be part of our success story.

Apply below or reach out to Joy Celebre today to learn more!

 

What you will be doing:

  • Reporting to the CEO, you will be a key part of the management team.
  • Acting as the primary point of contact with the FDA for all product approvals and regulatory matters.
  • Building a regulatory department for a growing startup, hiring and defining overall strategy for the team.
  • Working in tandem with the clinical affairs team to develop effective post-market trials.

What you must have:

  • An expert level of knowledge of medical device regulatory procedures and submission process, especially for orthopedic, sports medicine, or biologic products.
  • A collaborative mindset, strong communication skills and a desire to work cross functionally to succeed as a group.
  • Strong leadership capabilities, able to lead from the front, hire, and inspire a team of regulatory professionals.

Compensation: Competitive with substantial equity
Travel: Limited
Years of Experience: 10+
Degree: BS/BA Required
Location: Virginia

This job description is not intended to be all-inclusive and may have been abbreviated or maximized for online or mobile viewing. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Legacy MedSearch was named to the 2019 and 2020 Forbes list of Best Recruiting Firms in America

Job Requirements

Regulatory,

Meet Your Recruiter

Joy Celebre
Account Manager | Recruiter

Joy focuses on Cardiovascular positions. She has recently filled the following roles: Director of Marketing, Product Manager, Field Marketing, Sales, Director of Sales, Reimbursement Manager, Clinical Nurse Manager, Clinical Specialist, Director of Operations, Director of Quality as well as well as several confidential VP level searches. She has worked for Legacy MedSearch since 2008 in various roles and is very connected in the Medical Device community.

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.