Director, Medical Devices & Combination Products

Application deadline:  
Location: Madison 07940, New Jersey, United States 
Contract type: Permanent 
Job ID: 4025 

Your Role 

As Director, Medical Devices & Combination Products, you will shape global regulatory CMC strategy for our development and commercialized device combination products.  You will translate governance decisions into actionable regulatory roadmaps that accelerate market access, support efficient submissions and approvals, and ensure compliance with FDA, EMA, EU MDR, and other applicable global standards.  

Your Responsibilities 
•    Develop, plan and execute global regulatory strategies for Drug Device Combination Products in development and during life-cycle maintenance: ensuring alignment with FDA (21 CFR Parts 3/4/801/820), EMA/EC (EU MDR and Article 117), and relevant ISO standards . 
•    Authority engagement: lead and negotiate with FDA (including OCP), EMA/EC, Competent Authorities, and Notified Bodies; secure NB opinions and align on evidence requirements;  
•    Translate governance decisions into executable regulatory roadmaps with clear timelines, deliverables, and cross-functional accountability across Development, Technical functions QA, Clinical Operation, and Commercial. 
•    Anticipate regulatory risks and opportunities. Develop evidence-based scenarios and mitigations covering design controls, human factors validation, component/supplier changes, and CMC interfaces (extractables/leachable, drug–device compatibility, container closure integrity).  
•    Drive the strategy for evidence and data generation assessing the requirements for HF studies, biocompatibility matrices, sterilization validation, packaging/distribution validation, software documentation etc. Lead submission excellence and readiness across CMC for combination products to streamline reviews for global filings 
•    Work with the Global Regulatory Team (GRT) to implement strategies and the Regulatory Project Plan, ensuring alignment across Global Regulatory Affairs (GRA) for combination products. 
•    Provide regulatory leadership on Drug Device Combination product matters in cross-functional teams, using your expertise in Devices and regulatory insight. 
•    Lead device specific labeling strategy and claims discussion
•    Establish  regulatory intelligence initiatives, and policy shaping mechanisms, distilling external guidance into internal recommendations.  Engage with Industry bodies to inform and shape policy.  
•    Collaborate with internal teams across development, Technical functions , QA, clinical, and commercial to streamline submissions and regulatory compliance. 
 

Your Qualifications  

•    A Bachelor’s or Master’s degree in engineering, pharmaceutical sciences, regulatory affairs, or a related field (an advanced degree is preferred). 
•    12+ years of increasing responsibility in global regulatory affairs for Drug Device Combination Products with a proven track record in CMC/technical leadership. 
•    Expert knowledge of FDA, EMA/EC, EU MDR and global device/combination product regulations, standards, and pathways; deep familiarity with 21 CFR Parts 3/4/801/820; EMA Article 117 processes; NB opinion workflows. 
•    Advanced expertise across device standards and evidence: ISO 13485, ISO 14971, ISO 10993 series, ISO 11135/11137, ISO 11607, IEC 62366, IEC 62304; cybersecurity expectations; UDI/EUDAMED and labeling requirements (EU MDR Annex I GSPRs). 
•    Proven leadership of Technical Files/Design Dossiers, PMA/510(k)/De Novo submissions, and integration of combination product requirements into NDA/BLA filings. 
•    Strong knowledge of CMC-device interfaces, including extractables/leachables, drug-device compatibility, and packaging/sterilization validations. 
•    Exceptional leadership and mentoring skills, with experience in capability building and establishing processes and frameworks for regulatory excellence . 
•    Strong communication and collaboration skills within cross functional teams. Skilled in negotiationand engagement with  Agencies and Notified Bodies. 
•    Proven ability to navigate complex regulatory landscapes, anticipate risks, and influence senior governance decisions. 

The base salary range for this position is $175,000-240,000 per year. The base salary range represents the anticipated low and high of the LEO Pharma range for this position. Salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Certain roles may be eligible to earn commissions/bonus based on company and / or individual performance. 

LEO Pharma offers a competitive benefits package including medical, dental, and vision coverage, employer-paid life and disability insurance, a 401(k) retirement plan with employer match; and paid time off.

Beyond the skin

Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact.  Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet. 
 
LEO Pharma Inc. is an Equal Opportunity/Affirmative Action Employer. At LEO Pharma, we believe that our different perspectives, backgrounds, and attitudes are what enable us to make the best decisions, foster an inclusive culture, and meet the needs of the market we operate in. Therefore, we encourage you to apply for the position if you are excited about the role – even if you don’t meet every single requirement listed, you might be just the pioneer we are looking for. With this in mind, applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. We believe in flexibility in all aspects - also when it comes to supporting our employees' diverse needs, hence, we offer hybrid work opportunities whenever possible.

For certain positions, LEO Pharma might complete a background check conducted by a third party.

LEO Pharma Inc. seeks information for job applications from candidates in the U.S. through only the following channels:
•    the LEO Pharma Inc. website and Halogen Talent Acquisition, powered by Jobvite
•    via email to/from addresses using only the LEO Pharma domain of "@leo-pharma.com"
•    screening and interaction by telephone and through the Microsoft Teams platform.
Please note:
•    LEO Pharma does not use Google Hangouts, Zoom or any other platform for any recruitment-related activities.
•    Disregard any solicitation or request for information related to job applications with LEO Pharma via any other means and/or using email addresses with any other domain.
•    LEO Pharma will never ask candidates to make any type of personal financial investment related to gaining employment with the company.
 

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