On a retained basis, Weber & Company recruits for Medical Device start-ups and Fortune 500 companies.
Our clients are leaders in a broad range of product markets including orthopedics, instrumentation, cardiology, and minimally
invasive surgery, as well as in-vitro diagnostics.
List of current opportunities we are working on (click the job title to see full descriptions):
Director Regulatory Affairs
Salary: $145,000 to $180,000 + bonus + relocation
Location: San Antonio, TX
Startup Medical Device company seeks strong Executive level Regulatory and Quality leadership as they strive to commercialize an exciting PMA medical device that is forecasted to change the game within the imaging technology niche. As the Director of Regulatory Affairs you will be working directly with the company President and CEO on strategic initiatives towards the launch of a complex electro-mechanical medical device in a highly collaborative environment that will allow you to wear many hats. This position will drive pre and post market FDA interactions, including driving Regulatory strategy at the product and system level. Additionally, it will be your responsibility to ensure compliance to the FDA as the company makes their final push towards PMA approval.
- Possess a strong Regulatory Affairs background in the Medical Device industry. A background in imaging products preferred.
- Must possess a successful track-record of new product FDA approvals.
- Experience with complex software-driven electro-mechanical is also required.
- Thrive in a start-up company environment where everyone enjoys being hands-on.
- Excellent communicator, technically savvy person. Capable of advancement.
- Must possess a Bachelor's Degree in Science or Engineering discipline. Advanced degrees are preferred.
Senior Director Quality Assurance
Location: Merrimack, NH Area
Salary: $180,000 - $225,000 + Bonus + Relocation
Our client, an international medical device company is seeking to hire a Senior Director Quality Assurance to oversee 3 of their manufacturing locations. This position, which includes managing an international facility, is tasked with leading the final push to lift the company's consent decree and leading the quality group into the next phase of overall compliance. As part of this final push to lift the consent decree you will interact directly with the FDA, driving the final changes needed to end a long turnaround process. This position will require excellent communication and negotiation skills as you collaborate with the peers in other departments to bring everyone together and into compliance through new internal policies and procedures. This high-profile position is looking for someone ready to come in and be leader who drives change.
- Experience working in the medical device field in a quality management role with direct reports.
- Expertise using Quality Systems and Quality Engineering tools in a FDA regulated manufacturing environment.
- Fluent in FDA and Compliance regulations.
- Demonstrated extensive experience in ensuring compliance with Domestic and International regulatory requirements and regulating bodies required.
- Experience manufacturing cardio or software driven medical device preferred.
- Bachelor's Degree required, Advanced Degrees preferred.
Location: Greater Atlanta Area
Salary: $155,000 - $170,000
Our client is a multinational biotechnology company seeking to hire a Plant Director for their Atlanta-based, state-of-the-art manufacturing site. As the facility's operational head, you will be tasked with bringing some much-needed stability and congruency to the role, fixing broken systems, and driving throughput to create an overall sense of progress. Your goal will be to create organizational forms, which allow a quick and flexible reaction to changing expectations in the market including but not limited to: flexibility of working time, shift models, and teamwork across all departments.
- Experience working in a biotechnology or pharmaceutical environment required.
- Experience working in an aseptic or terminal sterilization environment required.
- Prior supervisory experience including mentoring, leadership and conflict management.
- Strong communications skills.
- Bachelor's Degree in Life Sciences or related field. Advanced degree a plus.
Directory Regulatory Affairs
Location: San Diego, CA
Salary: $170,000 to $195,000 + incentives + relocation
Our client is a market-leading medical device and IVD company looking for a new Director of Regulatory Affair. Your position will be to drive the workflow of a well-established and motivated regulatory team in need of a dynamic leader. As the Regulatory leader, you will create standardized processes for all divisions of the company umbrella as this company has acquired approximately 40+ companies in the past decade. It will be this position that helps drive the submissions processes for all groups including updating all systems to meet the latest in UDI standards. This company's novel technology needs a project leader that knows the regulatory strategies that will make a good team into a great team.
- Regulatory Affairs experience in the medical device industry
- Experience working with medical device or diagnostic product lines
- Excellent spoken and written communications skills
- Successful track record in Regulatory Affairs for a multi-region team
- Experience working FDA regulators/submissions
- B.S. in a science or advance degrees preferred
Senior Quality Engineer
Location: San Juan, PR
Salary: $80,000 - $95,000 + bonus
Our client, a leading player in least-invasive surgical devices, has an opening within its Quality Engineering department.
We are looking for an outstanding engineer with at least three years of hands-on experience in Manufacturing Process Validations (IQ, OQ, PQ) and Design Assurance and/or product testing in a GMP and ISO 9001/9002 certified medical device manufacturing environment.
Vice President of Regulatory Assurance
Location: San Francisco, CA
Our client, a growing diagnostic company, has a distinctive Executive Level leadership position that will challenge all of your skills and accelerate your career! They are looking for a Vice President of Regulatory.
You are a seasoned leader who possesses the right combination of business savvy, leadership, and technical skills to plan, scale-up and champion the implementation of an advanced quality system in compliance to FDA guidelines; within the context of an extremely rapid growth, can-do environment.
As part of the Executive Management team, qualified candidates must be fluent in interpreting and implementing QSR and IVD regulatory guidelines. You must possess advanced quality engineering skills to include validation, reliability, and design assurance in a highly automated, high volume-manufacturing environment. Must have Medical Device experience. BS in Science/Engineering and advanced degree preferred.
Sr. Regulatory Affairs Associate
Location: San Diego, CA
High-visible role preparing Class III regulatory submissions and strategy for market leading active implantables manufacturer.
Our client, who owns 80% of their core market and has achieved double-digit growth figures over the last six years, needs a seasoned Regulatory professional to tackle 510k and PMA submissions in support of three business units.
You must be able to negotiate with the FDA, preparing regulatory strategy, manage clinical information and prepare 510k submissions. Electromechanical, Implantable, or Class III experience a plus! Medical device experience required!
Director Regulatory Affairs
Location: Chicago, IL
Salary: $140,000 to $175,000 base salary + bonus + relocation
Newly created opportunity to lead an emerging technology platform within a multi-billion dollar Medical Device firm. This exciting new opportunity will be responsible for developing & executing a Global Regulatory strategy for a new and complex medical device/ IVD program. Enjoy all the feel of a truly exciting start-up environment, along with the great stability & benefits that come with working at a dominant market-leader. The Global Director will be a a hands-on leader with responsibility for: building a Global Regulatory Affairs team; serving on core functional teams with other R&D, Marketing, Clinical and Operations leaders; preparing & managing the creation and submission of regulatory documents; representing with FDA and Notified Body interactions/negotiations; and gaining product approvals worldwide.
- Qualified candidates much have extensive experience authoring Regulatory submissions to FDA for on-time approvals of new Medical Device and In-Vitro Diagnostic products for the global markets.
- Must have prior experience interacting directly with regulatory bodies on issues related to the regulatory approval of novel technologies.
- Must posses a track-record of supporting test plans needed for Medical Device IVD product submissions.
- Must have a BS or BA, at minimum, in a life sciences specialty; preferably medical technology, biochemistry or chemistry.
- Also must possess prior experience managing other Regulatory Affairs professionals in a Medical Device or IVD organization.
Director Quality Assurance
Location: Denver, CO
Salary: $97,000-$115,000 plus bonus
Exceptional, multi-plant leadership opportunity, as a Director of one the Medical Device Industry's most progressive & fast-paced companies. Our client, has rolled up several competitors; thus requiring a "hands-on" executive, who will innovate and develop advanced quality systems for its 3 manufacturing facilities. You will, at the plant level, mentor site quality managers, direct quality systems initiatives and help the company exceed its strategic objectives.
Medical Device experience is a must. Qualified candidates should also have at least six years progressive management experience and outstanding coaching/interpersonal skills. Technically, the most qualified candidates will possess superior, hands-on, knowledge of advance quality engineering and system skills, such as process validation; product introduction and transfer; managing within FDA guidelines.