Regulatory Device CMC Manager (EMEA or US based)

Syneos Health; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Syneos Health is seeking a Regulatory Device CMC Manager to lead regulatory strategies for device components of combination products in the US and/or EMEA. You will prepare and submit CMC documentation and provide regulatory guidance to cross-functional teams.

Key responsibilities include supporting submissions, ensuring global regulatory compliance, and contributing to Human Factors studies for devices. A strong background in FDA/EMA/regulatory guidelines is required.

Qualifications

• Bachelor’s degree in Biomedical/Mechanical Engineering, Biology, Chemistry, Pharmacy, Regulatory Affairs or related life-science field.
• Typically requires 4 years of experience in the medical device, pharmaceutical industry or related field, or the equivalent combination of education and experience.
• Experience supporting regulatory submissions/filings for combination products (autoinjectors, pre-filled pens, syringes).
• Experience supporting Human Factors studies for devices and combination products.
• Preferred experience with infusion systems/devices for drugs/cell therapies.

Responsibilities

• Develop and lead regulatory strategies for device components of combination products.
• Prepare and submit regulatory CMC documentation for device portions.
• Provide regulatory guidance to cross-functional teams to ensure global compliance.
• Support Human Factors studies and device submissions as needed.
• Collaborate with FDA, EMA, ISO bodies and Notified Bodies to ensure timely approvals.

Skills

Interpersonal skills

Regulatory knowledge

Regulatory guidelines

Problem solving

Collaboration

Planning & prioritization

Design Controls & standards

Education

Bachelor’s degree or equivalent in a life-science/engineering field

4 years of experience in medical device/pharmaceutical regulatory roles

Job description

Regulatory Device CMC Manager (EMEA or US based)

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know:

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

General Position Summary

The Device CMC manager will support strategies for marketed and development products. This role contributes to the preparation and submission of regulatory CMC documentation for device part of the combination device. This role also provides regulatory support and guidance to various cross functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into development and commercial programs.

Required Education Level & Experience

• Bachelor's degree, with a preference in Biomedical Engineering, Mechanical Engineering, Biology, Chemistry, Pharmacy, Regulatory Affairs, or another related life-science field
• Typically requires 4 years of experience in the medical device, pharmaceutical industry or related field, or the equivalent combination of education and experience
• Experience supporting regulatory submissions/filings for combination products, including autoinjectors, pre-filled pens, and/or pre-filled syringes
• Experience supporting Human Factors studies for devices and combination products
• Preferred experience with infusion systems/devices for drugs/cell therapies

Required Knowledge/Skills

• Strong interpersonal skills to exchange complex information with others and to guide others
• Knowledge of combination product and device regulatory requirements (FDA, EU MDR, GSPRs)
• Proficiencyin regulatory (FDA,Notified Body, MDCG, EMA, ISO, etc.) guidelines
• Strongproblem-solvingskills
• Ability to collaborate and communicate in an open, clear, complete, timelyand consistent manner
• Strong senseof planning and prioritization, and the ability to work with all levels of management
• Sound knowledge of Design Controls, cGMP, FDA, EMA, ISO Standards (ISO 13485, ISO 14971, IEC 62366, ISO 10993, ISO 11608, ISO 11040, etc.)

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

CMC expertise in small molecule experience with support to Regulatory team with Global expansion on multiple markets. Veeva RIM authoring is required.