Senior Regulatory Affairs Specialist

Smith+Nephew•Minneapolis, MN

20d•Hybrid

About The Position

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Are you passionate about navigating regulatory landscapes? Do you thrive in fast-paced environments? We're looking for a Sr. Regulatory Affairs Specialist to join collaborative and energetic team working on regulatory submissions and compliance maintenance for Smith+Nephew. If you're ready to make an impact, apply now!

Requirements

Bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline (RAPS Certification or RA Master’s degree a plus).
Minimum of 5 years’ regulatory experience or equivalent within the medical device industry or similar industries.
Demonstrated experience with successful submissions in key markets such as US and EU.
Demonstrated knowledge of regulatory requirements, standards and guidance for medical devices.
Processes and Product Lifecycle Management Systems experience is required.
Knowledge of regulatory compliance requirements (e.g. 21 CFR 820, ISO13485:2016, EU MDR, GMP etc.)
Ability to interpret and apply regulations, respond effectively to inquiries from regulatory agencies (both in writing and in person), and prepare detailed technical regulatory submissions, reports, and business correspondence.
Strong interpersonal and communication skills, including technical writing, active listening, and clear verbal expression; proven ability to collaborate effectively with large cross-functional and diverse teams.
Analytical and agile problem-solver with a high capacity for learning; self-motivated and solution-oriented, able to work independently and within teams, and adept at applying innovative approaches to complex challenges.
Excellent organizational and time management skills, with the ability to prioritize and handle multiple demands in a dynamic, fast-paced environment.

Nice To Haves

RAPS Certification or RA Master’s degree a plus

Responsibilities

Preparation and review of global regulatory submissions, including US 510(k) and EU technical documentation, and support regional regulatory colleagues in the preparation of international regulatory submissions for new and modified devices.
Work as the RA lead on project teams independently to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company’s product launch timelines in all identified markets.
Manage/lead regulatory-driven project, as directed by management.
Develop and execute global regulatory strategies and support product release for market expansion activities for new and modified products.
Maintain a working knowledge of global regulations, standards, guidance documents, country-specific requirements, medical devices and medical terminology.
Plan, lead and support for internal and Regulatory agency audits.
Lead and direct engagement with regulatory authorities as required.
Initiate and manage regulatory change assessments (e.g., design, labeling, manufacturing process changes) to determine impact to domestic and international product registrations, updating registrations as required to maintain regulatory submission compliance.
Develop and maintain company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements.
Provide technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
Review product labeling to ensure compliance with regulatory requirements.
Other activities as assigned.

Benefits

medical, dental, and vision coverage
401k
tuition reimbursement
medical leave programs
parental leave
generous PTO
paid company holidays annually and 8 hours of Volunteer time and a variety of wellness offerings such as EAP
401k Matching Program
401k Plus Program
Discounted Stock Options
Tuition Reimbursement
Flexible Personal/Vacation Time Off
Paid Holidays
Flex Holidays
Paid Community Service Day
Medical, Dental, Vision
Health Savings Account (Employer Contribution of $500+ annually)
Employee Assistance Program
Parental Leave
Fertility and Adoption Assistance Program
Discounts on fitness clubs, travel and more!