Sr Specialist, Regulatory Affairs (Medical Device)

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Job Summary:

The Regulatory Affairs Sr. Specialist is responsible for influencing department regulatory processes and procedures, developing strategies for worldwide labeling and change control coordination for Administration and Safety System medical devices.  Responsible for leading projects in support of product labeling activities throughout various stages of design and development of delivery systems and combination products.  Maintain knowledge of current FDA, EMA and international regulations/guidelines/policies related to medical devices as applicable to West’s products and services.

 

Essential Duties and Responsibilities:

• Accountable for initial creation and control process for labeling of administration and safety systems in the form of development and maintenance of labeling proofs, associated labeling documents, maintain labeling issuance and tracking systems, and provide status updates to management change requests and notification to stakeholders, ensuring documents are produced in a timely manner in accordance with West procedures and regulatory requirements
• Initiate and support change control processes for global product registration, submission and post marketing of Administration and Safety System medical devices in West’s portfolio
• Create, guide, and advise on internal labeling guidance and policies, including product labels, Unique Device Identification (UDI), Instructions for Use (IFUs) and promotional materials
• Lead meetings with cross-functional teams to review and approve labeling proof documents ensuring completeness and accuracy in accordance with regulatory and marketing requirements
• Provide strategic input to internal partners and manage feedback from stakeholders on labeling requirements and issue resolution
• Monitor, interpret and communicate existing and new regulatory requirements related to labeling for Administration and Safety System portfolio
• Collaborate with Regulatory Affairs (RA) submission teams to support timely and quality regulatory submissions and approvals globally
• Contribute and support continuous improvements to the end-to-end labeling and change control processes including policies, procedures, quality, and system tools
• Advise and guide internal and external customers on regulatory strategies, regional regulatory risks that may impact the business as applicable to labeling
• Develop specific objectives and manage work assignments, with minimal guidance to achieve labeling objectives in conformance with global regulatory and business goals
• Other duties as assigned

 

Basic Qualifications: 

• Education:  Bachelor’s, Master’s degree or PhD in science, math, engineering, or related discipline
• Experience:   Bachelor’s with 5+ years; Master’s degree/PhD 2+ years medical device regulatory experience

 

Preferred Knowledge, Skills and Abilities:

• Minimum US Class II and EU Class IIa device experience and in-depth knowledge of US FDA regulations (Title 21) and EU MDD (93/42/EEC) and MDR (2017/745)
• Advanced knowledge of 21 CFR 803 and 820/ISO 13485
• Ability to work effectively in multinational/multicultural environment
• Ability to manage complex projects and timelines in a matrix team environment
• Strong interpersonal, communication, negotiation, and presentation skills
• Ability to mentor and guide others
• Ability to independently identify compliance risks and escalate when necessary
• Regulatory compliance competency including Quality Systems
• International regulatory competency
• Advanced degree 
• R.A.C certification(s)
• Experience with administration and drug