Senior Regulatory Affairs Specialist (Remote)

Sr. Regulatory Affairs Specialist (remote)

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.   

This role will be focused on, Biologics, one of the fastest growing and exciting product lines at Smith + Nephew that involves novel absorbable and non-absorbable implant and delivery technologies to serve our patients and customers in the shoulder repair market.  This position is ideal for an experienced regulatory professional capable of providing technical contribution and leadership on medium scale projects and / or multiple projects.  The candidate will be required to build strong relationships across the organization to shape the direction of the product.

What will you be doing?

• Coordinates associated registration or submissions leading to market clearance/approval. 

• Provide regulatory direction to project teams for product development/design control related activities. 

• Drafting, authoring and submitting PMA’s to regulatory agencies including US FDA and global regulatory authorities.

• Ensure regulatory compliance throughout the life cycle of the product by assessing product changes for impact to registrations/licenses. 

• Maintain databases as required and support regulatory compliance projects as assigned.

• Develops and implements regulatory strategies for new and modified products and regulatory processes and prepares submissions to obtain and maintain global regulatory approvals of products, providing oversight of device labeling and advertising and promotional materials to ensure continued compliance to global regulations.

• Provides regulatory guidance and direction as a core team member on development and manufacturing teams, as well as compliance projects, throughout the product development life cycle, and identifies/coordinates cross functional deliverables.

• Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.

• Reviews and approves product and manufacturing changes for compliance with applicable regulations.

• Prepares, reviews, and maintains technical documentation including Design Dossiers and Technical files, and works with relevant team to resolve issues.

• Acts as company representative, developing and maintaining positive relationships with regulatory agency reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.

• Prepares for and assists with external audits such as MDSAP or Notified Body technical audits.

What will you need to be successful?

• Education: bachelor’s degree in biomedical engineering or Biological Engineering, or equivalent Life Sciences Science discipline.

• Licenses/Certifications: RAC Preferred.

• Experience: 5+ years in Regulatory Affairs with Product Development experience.  (Required). Experience with implantable or novel devices preferred.

• 3-5 years of extensive experience in managing the premarket approval (PMA) complete submission processes

• 3-5 Regulatory compliance, Global Submissions, 510K, Product development, Change Controls, MDR Technical Documentation (class III) creation and maintenance and process management.

• Knowledge and practical application of medical device product development regulations (ISO, GMP, FDA, CE, EU MDR) and design controls.

• Experience in Biologics, FDA Q-Sub, Internal/External Audits, Quality Systems expertise and clinical trial experience beneficial

• Travel Requirements: <10%

The anticipated base compensation range for this position is $115,000.00 - $130,000.00 USD annually and the compensation offered will depend on the candidate’s qualifications. You may also be entitled to receive bonus and benefits, which may include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, and a variety of wellness offerings.

Smith & Nephew follows the Pay Transparency and non-discrimination provisions described by local and state policies.

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. 

Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ).

Other reasons why you will love it here!

• Your Future:  401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement  
  Work/Life Balance:  PTO, Paid Holidays, Flex Holidays, Paid Community Service Day  

• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program

• Flexibility: Hybrid Work Model (For most professional roles)

• Training: Hands-On, Team-Customized, Mentorship

• Extra Perks: Discounts on fitness clubs, travel and more

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

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