What are the responsibilities and job description for the Senior Regulatory Affairs Specialist (WA) (1 of 2) position at Bausch Health Companies Inc.?
Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek dedicated individuals who share our sense of urgency, unity, and excellence.
We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future.
We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact.
Principle Responsibilities and Duties:
Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.
The Sr. Regulatory Affairs Specialist provides direct support to Solta operations for their globally distributed products. They will work closely with site Quality, R&D, Operations, and regional peers to support global licensing and registrations, and to ensure effective execution and management of changes.
About the role:
Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, 3-weeks paid time off plus 6 days paid sick time (unless a state or city-specific policy applies) to start (pro-rated for new hires), tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, 12 paid holidays (including floating holidays), Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.
T his position may be available in the following location(s): [[location_obj]]
We thank you in advance for your interest in growing and developing with our company. Kindly note that in order for all stakeholders to be successful, we do require a minimum of one year in your current role before applying to another one. Please ensure you have discussed with your current manager the intent of applying to a new role.
Any exception will have to be authorized by your HR Business Partner.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.
If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to humanresources@bauschhealth.com or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please read Job Offer Fraud Statement (https://www.bauschhealth.com/siteassets/pdf/bausch-health-fraud-statement.pdf) .
Bausch Health is an EEO/AA employer M/F/D/V.
We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future.
We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact.
Principle Responsibilities and Duties:
Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.
The Sr. Regulatory Affairs Specialist provides direct support to Solta operations for their globally distributed products. They will work closely with site Quality, R&D, Operations, and regional peers to support global licensing and registrations, and to ensure effective execution and management of changes.
About the role:
- Participates in the development of regulatory strategies and plans for new product launch & authors submissions for major markets (US, Canada, EU) as assigned.
- Evaluates product changes for impact to existing markets.
- Creates and fosters changes through the change review process.
- Provides regulatory expertise to the R&D and Operations teams, including labeling requirements and submissions approval lead times for new product development (NPD) and sustaining engineering changes.
- Conducts research and communicates new and revised regulatory requirements to the organization, performs/coordinates impact assessment activities, and supports implementation of changes as required.
- Communicates with regulatory agencies through oral and written communications regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, clarification and follow-up of submission under review.
- Audit/Support regulatory related submissions to relevant countries: US, Canada, China & EU.
- Represent Regulatory team in cross-functional meetings.
- Assists with developing, refining, and documenting internal regulatory processes and procedures.
- Experience with APAC (China) a plus not a requirement.
- This position requires a minimum of an undergraduate degree, preferably in a science related field.
- Should have 3-5 years’ experience as a Regulatory Affairs Specialist and/or Sr. Regulatory Affairs Specialist.
- Should have experience authoring complete 510(k) submissions, Medical Device license applications (Class II or above), EU MDR technical file dossier (Class II or above).
- Must have a solid understanding of Change Management/Life Cycle Management of medical device products along with the impact of changes on US Canada and EU.
- Possess a self-directed & problem-solving mindset.
- Must possess the ability to work highly effectively in cross-functional teams and must thrive in a dynamic, fast-paced environment.
- Excellent written and communication skills.
- Please note, the head office is in Bothell Washington, and this is a Westcoast operation.
Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, 3-weeks paid time off plus 6 days paid sick time (unless a state or city-specific policy applies) to start (pro-rated for new hires), tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, 12 paid holidays (including floating holidays), Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.
T his position may be available in the following location(s): [[location_obj]]
We thank you in advance for your interest in growing and developing with our company. Kindly note that in order for all stakeholders to be successful, we do require a minimum of one year in your current role before applying to another one. Please ensure you have discussed with your current manager the intent of applying to a new role.
Any exception will have to be authorized by your HR Business Partner.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.
If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to humanresources@bauschhealth.com or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please read Job Offer Fraud Statement (https://www.bauschhealth.com/siteassets/pdf/bausch-health-fraud-statement.pdf) .
Bausch Health is an EEO/AA employer M/F/D/V.
Salary : $95,000 - $130,000
