Regulatory Affairs Manager

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

What will you be doing?

• Responsible for the creation and execution of global regulatory strategies for new product development activities and all medical devices through their product lifecycle

• Directly, or through subordinate staff, develops regulatory submissions and dossiers; conducts submission negotiations with regulatory agencies, as needed, including pre-submission identification of requirements and strategy to ensure timely approval.

• Responsible for resourcing NPD programs and portfolio maintenance activities, translating regional regulatory needs into project inputs and ensuring those inputs become deliverables that can be provided to regional team members to facilitate the preparation of new submissions, product renewals, tender requests, etc.

• Builds effective partnerships with RA teams across franchises and regions and with appropriate functional teams (e.g., program management office (PMO), marketing, research and development (R&D), quality, operations)

• Maintain a working knowledge of existing and proposed regulations, standards and guidance documents, internal procedures, and facility registration, device listing and import/export requirements.

• Assists in the development of departmental and corporate Standard Operating Procedures and departmental procedures, when necessary.

• Provides support for internal and external regulatory agency audits, corrective and preventive action (CAPA) activities, health hazard evaluations (HHE) and field actions.

What will you need to be successful?

• Education: bachelor’s degree preferably in an engineering, clinical, medical, or scientific/technical discipline; Biomedical engineering degree preferred but not required

• Experience: Minimum 5 years Regulatory experience required and medical device experience preferred.

• 1-2 years supervisory experience preferred.

• Orthopedic device experience preferred.

• Good interpersonal/communication skills are essential.

• Experience of providing Regulatory Advice to the business is essential.

• Ability to handle multiple demands in a fast-paced environment.

• Demonstrated strategic thinking with the tactical and operational experience to deliver objects/results, proven ability to influence cross-functional teams, strong planning and analytical skills

• Leadership if any: People Manager (team of 3-5)

• Travel Requirements: <10%

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

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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.