Senior Regulatory Affairs Specialist at SMITH NEPHEW PTE LIMITED

Mansfield, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

21 Aug, 26

Salary

152250.0

Posted On

23 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, Regulatory Submissions, FDA 510(k), EU MDR, Technical Writing, Compliance Management, Regulatory Intelligence, SOP Development, Cross-functional Collaboration, Medical Device Development

Industry

Medical Equipment Manufacturing

Description

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Are you a regulatory affairs professional who enjoys working at the intersection of innovation, compliance, and patient impact? Join our growing Sports Medicine franchise and play a key role in supporting life changing medical technologies used by patients around the world. This is an opportunity to work collaboratively with global teams while shaping regulatory strategy across the full product lifecycle. What will you be doing? Developing and executing global regulatory strategies for new and modified medical devices Preparing and managing regulatory submissions to obtain and maintain global market approvals Providing regulatory guidance to cross functional teams across product development, manufacturing, and compliance activities Assessing product and manufacturing changes to ensure continued regulatory compliance throughout the product lifecycle Acting as a company representative with global regulatory agencies, building and maintaining strong professional relationships Supporting regulatory audits, advocacy initiatives, and regulatory intelligence activities Developing and maintaining regulatory SOPs and providing training and mentoring to colleagues What will you need to be successful? Bachelor’s degree or equivalent experience, preferably in a scientific or technical discipline 5 or more years of Regulatory Affairs or related experience within the medical device industry Proven experience managing FDA 510(k) submissions and EU MDR filings Strong understanding of global regulatory requirements and medical device development processes Excellent written and verbal communication skills, including technical writing RAPS certification is an advantage The anticipated base compensation range for this position is $101,500.00 - $152,250.00 USD annually and the compensation offered will depend on the candidate’s qualifications, job-related knowledge/skills, geographical location. You will be entitled to receive bonus and benefits, which 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 and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/). Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement Work/Life Balance: Flexible Personal/Vacation Time Off, 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 Training: Hands-On, Team-Customized, Mentorship Extra Perks: Discounts on fitness clubs, travel and more! #LI-HYBRID #LI-SB2 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. Stay connected by joining our Talent Community. We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer. Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Nephew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.

How To Apply:

Incase you would like to apply to this job directly from the source, please click here

Responsibilities

Develop and execute global regulatory strategies for new and modified medical devices while managing submissions for market approvals. Provide regulatory guidance to cross-functional teams and maintain professional relationships with global regulatory agencies.